Azpipeline_org

Agriculture, Food & Natural Resources

Clinical Research Coordinators

Plan, direct, or coordinate clinical research projects.

Salary Breakdown

Clinical Research Coordinators

Average

$101,340

ANNUAL

$48.72

HOURLY

Entry Level

$73,150

ANNUAL

$35.17

HOURLY

Mid Level

$97,030

ANNUAL

$46.65

HOURLY

Expert Level

$120,910

ANNUAL

$58.13

HOURLY


Current Available & Projected Jobs

Clinical Research Coordinators

14

Current Available Jobs

930

Projected job openings through 2024


Sample Career Roadmap

Clinical Research Coordinators

Degree Recommendations








Top Expected Tasks

Clinical Research Coordinators


Knowledge, Skills & Abilities

Clinical Research Coordinators

Common knowledge, skills & abilities needed to get a foot in the door.

KNOWLEDGE

Medicine and Dentistry

KNOWLEDGE

English Language

KNOWLEDGE

Administration and Management

KNOWLEDGE

Mathematics

KNOWLEDGE

Clerical

SKILL

Reading Comprehension

SKILL

Active Listening

SKILL

Writing

SKILL

Coordination

SKILL

Speaking

ABILITY

Oral Comprehension

ABILITY

Written Comprehension

ABILITY

Oral Expression

ABILITY

Written Expression

ABILITY

Speech Recognition


Job Opportunities

Clinical Research Coordinators

  • Clinical Program Manager (Cigna Medical Group - Population Heal
    Cigna    Phoenix, AZ 85096
     Posted about 23 hours    

    Job Description Summary: The Population Health Management (PHM) Clinical Program Manager is responsible for developing, implementing, and optimizing programs that fulfill Cigna's triple aim of improved patient care, improved patient satisfaction with services, and improved cost of care for all populations managed by Cigna Medical Group (CMG). The Program Manager contributes to the clinical, quality, financial and patient satisfaction outcomes. The Program Manager serves as the clinical resource for PHM staff and ensures that PHM projects and programs are delivered timely and are completely integrated with the efforts of clinic operations and medical management. The Program Manager works closely with all members of the Care Management team. The Manager has deep knowledge of all PHM programs and can present them to diverse audiences. This position is also expected to support and, when appropriate, contribute directly to organizational clinical initiatives and programs. RESPONSIBILITIES: 1 Consistently exhibits behavior and communication skills that demonstrate Cigna Medical Group’s commitment to superior customer service and quality of care and shows concern for each and every internal and external customer 2 Plans, implements, manages and evaluates new or existing population health care strategies, programs and medical services that advance CMG’s triple aim for all populations managed by CMG. 3 Utilizes appropriate resources within the parameters of established contracts and health plan benefits. 4 Uses advanced nursing knowledge, experience and skills to ensure the appropriate utilization of resources and patient quality outcomes 5 Ensures that clinical and non-clinical staff members of the department produce coordinated treatment plans, appropriate care expectations, and address end of life issues, including Advanced Directives 6 Maintains patient confidentiality at all times 7 Responsible for all PHM program execution 8 Manages clinical and non-clinical managers in the PHM department 9 Ensures that all departmental services are delivered in a timely and comprehensive manner and that service is maintained at the highest level for internal and external customers 10 Partners with vendors and internal informatics/Business Support Services to provide measurement tools and reports that support clinical programs in PHM and throughout the organization 11 Supports efforts as requested to improve MAPD Star Ratings 12 Functions as a change agent within the department and assists with change throughout CMG 13 Continually works to improve PHM clinical management programs such as, Chronic Health Improvement Program (CHIP), Transition of Care Nurse Program and Care Coordination to ensure they deliver excellent services at lowest cost to the organization 14 Leads the integration of PHM programs into health care centers, specialty offices, and Custom Care Programs and educates the organization on the function, value, and methods of accessing PHM programs 15 Works with the Quality Manager for Government Programs, the Strategic Resource Group, Medicare Operations, and the Quality department to ensure that PHM programs fully support compliance with Medicare, Medicaid, and Commercial plans. 16 Works with the Collaborative Accountable Care team to establish best practices for management of Open Access Plan patients 17 Works with the Medicaid contracted entities to coordinate programs that support the Patient Centered Medical Home model 18 Will work with teams added in the future that require population health management strategies and programs 19 In association with marketing, develops supporting materials that improve patient engagement and help lead implementation of PHM programs within the organization. QUALIFICATIONS * Licensed Registered Nurse preferred. * Masters Degree in Business preferred * Minimum of 3-5 years’ experience in clinical practice * Minimum of 3 years of Managed Care clinical program development experience * Strong communication and polished presentation skills required in order to represent the organization to internal and external customers * Can show proof of success in the following areas: * Ability to drive results with real examples of successes * Projects/programs that have delivered high customer satisfaction (external and internal) * Good command of data management and development of data-driven processes that improve care, increase customer satisfaction and/or decrease cost. * Ability to inspire teams to new levels of performance * Project management skills including development, implementation, monitoring and measuring for success * Experience with Quality programs ideal (CQI, TQI, PDSA) SCOPE * Position is responsible for developing, implementing and managing clinical programs that assist the medical group deliver on the Triple Aim. REPORTING * Position reports to Medical Director of PHM. Critical Dependencies This position will work closely with all management throughout CMG. In addition to medical, nursing and clinical operations, he/she will be expected to form strong working relationships with other critical CMG departments such as specialty offices, informatics, finance, marketing and contracting, among others. The Program Manager will develop working relationships with departments that support external clinical offices and contracted entities to ensure that PHM programs are fully utilized and support enterprise-level goals. .
    Category: Healthcare Practitioners and Technical Workers, not listed separately.
    Experience: .


    Employment Type

    Full Time

  • Senior/ Clinical Research Associate, Neurology/CNS (Home-based) - IQVIA Biotech
    IQVIA    Scottsdale, AZ 85258
     Posted 2 days    

    IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

    In anticipation of future growth, IQVIA Biotech is proactively seeking to identify Sr. Clinical Research Associates/ Clinical Research Associates with Neurology/CNS therapeutic experience.

    IQVIA Biotech delivers flexible, tailored, clinical and commercial solutions designed for biotech and biopharma companies. From planning, through trial design and delivery, and commercialization, IQVIA Biotech brings simplified operating procedures, specialized, therapeutically-aligned teams, and advanced data science to provide a more agile way for our customers to reach their drug development and commercialization milestones.

    **BASIC FUNCTIONS:**

    Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also serve in the Lead CRA role.

    **ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    + Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborates with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Trains site staff on the EDC system and verifies site computer system.

    + Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.

    + May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.

    + Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensures internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensures all study deliverables are completed per IQVIA Biotech and study timelines

    + Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.

    + Serves as mentor for junior CRAs and those new to the company and/or study.

    + Performs other duties, as requested.

    **LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    The Lead Clinical Research Associate **may** perform any of the following tasks:

    + Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborate with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Train site staff on the EDC system and verify site computer system.

    + Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.

    + May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM.

    + May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.

    + Assist the study management in identifying and generating changes in scope

    + Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensure all study deliverables are completed per IQVIA Biotech and study timelines

    + May conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.

    + Serve as mentor for junior CRAs and those new to the company and/or study.

    + Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.

    + Review and approve CRA travel expenses and time sheets.

    + Perform other duties, as requested.

    **TECHNICAL CTM ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    The Technical CTM **may** perform any of the following tasks for oncology studies:

    + Create master tracker(s) to house information generated from various reports such as:

    + and _CM_Data_Cleaning_Report_By_Subject_ both Business Objects reports

    + Reconcile patients that have come off treatment and off study

    + Generate and review various IL2 reports

    + Works closely with CDRC to ensure data is further reviewed and discrepancies documented.

    + The Technical CTM may participate in CDRC review and aid in Patient Profile review, as necessary.

    + There may be additional tracking required as a result of CDRC’s review.

    **KNOWLEDGE, SKILLS AND ABILITIES:**

    + Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.

    + Four+ years of oncology experience and/or medical device.

    + Experience in monitoring and/or coordinating clinical trials required.

    + Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.

    + Demonstrated ability to form strong functional relationships.

    + Excellent, presentation, organizational and interpersonal skills.

    + Ability to interact with all levels of staff to coordinate/execute study activities.

    + Ability to handle several priorities within multiple, complex trials.

    + Ability to reason independently and recommend specific solutions in clinical settings.

    + Ability to work independently, prioritize, and work within a matrix team environment.

    + Ability to mentor other CRAs and co-monitor, as required.

    + Knowledge of electronic data capture including basic data processing functions.

    + Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.

    + Able to qualify for a major credit card, rent an automobile

    + For the Technical CTM role, the CRA must have a deep understanding of IQVIA Biotech systems with the ability to learn even more.

    **PHYSICAL REQUIREMENTS:**

    + Very limited physical effort required to perform normal job duties

    + Extensive use of telephone and face-to-face communication requiring accurate perception of speech

    + Extensive use of keyboard requiring repetitive motion of fingers

    + Regular sitting for extended periods of time

    **MINIMUM RECRUITMENT STANDARDS:**

    + BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is required; or equivalent combination of education, training and experience.

    + Prior Clinical Research Organization (CRO) experience preferred.

    + Prior project team leadership experience preferred.

    + Working knowledge of budget management preferred.

    + Must be able to travel domestically and internationally approximately 65%-85%.

    + Valid driver’s license

    + Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

    **CLASSIFICATION (US):**

    This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

    \#LI-AL3

    \#LI-Remote

    _Join Us_

    Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

    Forge a career with greater purpose, make an impact, and never stop learning.

    IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

    IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at _workday_recruiting@iqvia.com_ to arrange for such an accommodation.

    At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.

    Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.


    Employment Type

    Full Time

  • Senior/Clinical Trial Manager, Oncology (Home-Based,) - IQVIA Biotech
    IQVIA    Phoenix, AZ 85067
     Posted 2 days    

    IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

    In anticipation of future growth, IQVIA Biotech is proactively seeking to identify Sr. Clinical Trial Managers/ Clinical Trial Managers with Oncology therapeutic experience, CAR T trial experience a plus.

    IQVIA Biotech delivers flexible, tailored, clinical and commercial solutions designed for biotech and biopharma companies. From planning, through trial design and delivery, and commercialization, IQVIA Biotech brings simplified operating procedures, specialized, therapeutically-aligned teams, and advanced data science to provide a more agile way for our customers to reach their drug development and commercialization milestones.

    BASIC FUNCTIONS:

    Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities for CAR-T cell therapy studies. Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial. Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by IQVIA Biotech and its clients.

    ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

    Responsible for all activities related to implementation and execution of clinical studies that include:

    Client Duties/Responsibilities:

    + Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP.

    + Serve as client advocate within IQVIA Biotech.

    + Develop and implement Clinical Monitoring Plan.

    Team Duties/Responsibilities:

    Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:

    Coordinate site management activities:

    + Site identification, recruitment, and selection.

    + Regulatory document collection and review.

    + Overall scheduling and management of all site visits.

    + Develop site/monitoring tools and training materials.

    + Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.

    Coordinate and oversee daily operations of clinical monitoring team:

    + Set and enforce project timelines with the assigned study team.

    + Coordinate remote review of clinical data within EDC system.

    + Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract.

    + Review and approve trip reports and follow-up letters within required timeframe.

    + Schedule and manage weekly CRA project team meetings.

    + Ensure CRAs assigned to team receive therapeutic and project-specific training.

    + Manage quality and regulatory compliance among clinical monitoring team and investigational sites.

    Manage project milestones and proactively address deficiencies:

    + Attend and provide information at monthly projections meetings.

    + Attend and provide information at weekly client teleconferences/team meetings.

    + Assist Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization.

    Manage CRA performance:

    + Define and implement functional standards, goals, and expectations with clinical monitoring team.

    + Serve as CRA mentor and perform accompanied field assessment visits as required.

    + Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.

    Documentation Duties/Responsibilities:

    + Assure that the appropriate IQVIA Biotech and/or sponsor SOPs are followed.

    + Ensure all project documentation is appropriately filed per IQVIA Biotech SOPs.

    + Assist PM in preparation of audit responses, as appropriate.

    + Assist PM with preparation of information for inclusion in monthly report to client.

    Budget/Contract Duties/Responsibilities:

    + Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.

    + Define the scope of work with the client and clinical monitoring team.

    + Assist PM in identifying and generating changes in scope and notify client of potential changes in scope.

    + Review and approve CRA travel expenses and time sheets.

    KNOWLEDGE, SKILLS & ABILITIES:

    + Thorough knowledge of clinical research process.

    + Prior experience as a Clinical Research Associate.

    + Strong communication skills (verbal and written) to express complex ideas.

    + Excellent organizational and interpersonal skills.

    + Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.

    + Ability to manage multiple priorities within various clinical trials.

    + Ability to reason independently and recommend specific solutions in clinical settings.

    + Understanding of basic data processing functions, including electronic data capture.

    + Working knowledge of current ICH GCP guidelines and applicable regulations.

    + Able to mentor CRAs and more junior Clinical Trial Managers.

    + Able to qualify for a major credit card.

    + Valid driver’s license; ability to rent automobile.

    + Willingness and ability to travel domestically and internationally, as required.

    CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

    + Ability to travel domestically and internationally

    + Very limited physical effort required to perform normal job duties

    MINIMUM RECRUITMENT STANDARDS:

    + BS/BA (or equivalent) in one of the life sciences with a minimum of 4 years direct experience in clinical studies or equivalent level of education and experience.

    + Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis.

    + Minimum of 2 -3 years as a successful Clinical Trial Manager.

    + Excellent verbal and written communication skills.

    + Ability to work independently, prioritize and work with a matrix team environment is essential.

    + Working knowledge of Word and Excel.

    + Prior experience in electronic data capture (EDC) preferred.

    + Therapeutic Knowledge- CAR T cell therapy study experience required; additionally 2 years of solid tumor, hematologic oncology and oncology phase I experience strongly preferred

    \#LI-AL3

    \#LI-Remote

    _Join Us_

    Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

    Forge a career with greater purpose, make an impact, and never stop learning.

    IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

    IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at _workday_recruiting@iqvia.com_ to arrange for such an accommodation.

    At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.

    Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.


    Employment Type

    Full Time

  • Clinical Research Associate III (FHI Clinical)
    fhi360    Phoenix, AZ 85067
     Posted 2 days    

    Job Summary:

    The Clinical Research Associate (CRA) monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols. Reviews regulatory documents as required and prepares site visit reports. May be responsible for multiple projects and must work both independently and in a team environment. Participate in the study development and start-up process including reviewing protocols, designing and/or reviewing Case Report Forms (CRF), preparing Informed Consent Forms (ICF’s), developing study documents, organizing and presenting at investigator meetings, working with management on a monitoring strategy, and/or developing project-specific CRA training. S/he may participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. S/he may provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Prepares clinical documents, business correspondence, and procedural manuals. Maintain systems and process necessary to report trial status and activities; and to help ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget. Depending upon the level of experience, may become involved, when required, in other areas of study management and staff training and contributes to the review of sponsor/client’s and/or FHI360’s systems and procedures as appropriate.

    Accountabilities:

    + Assists in the preparation of routine protocols, informed consents, SOPs, and other appropriate documentation.

    + Monitors clinical trials to ensure subject safety and compliance with the study protocol, FDA regulations and ICH/GCP Guidelines, may be done with supervisor.

    + Coordinates necessary activities required to set-up, monitor, and close-out clinical trials sites.

    + Conduct site assessment, initiation, routine, and close-out monitoring visits, may require supervision.

    + Complete accurate monitoring visit reports.

    + Develops training materials and conducts training for study implementation based on company policies and SOPs.

    + Contributes to the development of and implements protocols and informed consents for research studies.

    + Provides guidance on any protocol related issues.

    + Manages and oversees budget for one or more research projects.

    + Develops, reviews, and maintains key study documents to ensure adequate resource and reference documentation.

    + May serve as a liaison with internal and external partners to ensure effective collaboration efforts.

    + Oversees planning of meetings, site visits, and drafting necessary documents.

    + Ensures compliance with government regulations when writing and reviewing protocols, analysis plans, reports, and manuscripts.

    + Provides input with questionnaire development, analysis, study design, and material management.

    + Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and FHI 360 Standard Operating Procedures.

    + Conducts site visits to assess protocol and regulatory compliance and manages required documentation.

    + Updates and maintains project specific tracking tools.

    + May function as project manager on assigned projects taking on a lead role of achieving specific milestone goals to completion.

    + Responsible for ensuring that data will pass international quality assurance audits.

    + Represents FHI360 in the global clinical research community and develops and maintains collaborative relationships with investigational sites and clients.

    Applied Knowledge & Skills:

    + Reviews and approves the work and written reports of team members.

    + Proven clinical monitoring skills.

    + Development and preparation of applicable study tools and job aids.

    + Demonstrates effective management skills to at least one staff member.

    + Demonstrates project management capabilities including: planning, tracking of milestones/deliverables, and monitoring of resources and budget requirements.

    Problem Solving & Impact:

    + Works on complex problems that require analysis or interpretation of various factors.

    + Exercises independent judgment in determining methods and techniques to accomplish results.

    + Decisions could have a major impact on the management and operations of an area within a department

    Supervision Given / Received:

    + Determines and develops plans and procedures on new assignments and directs the work of others.

    + Typically reports to a Manager/Director.

    + May act as team lead and mentors staff on training, systems, policies, and regulations.

    Education:

    + Bachelor's Degree or its International Equivalent • Education, Health, Behavioral, Life or Social Sciences, International Development, Human Development or Related Field.

    Experience:

    + Requires 5+ years of clinical research experience including assisting with protocol development, clinical monitoring, study implementation, study close out, project management, analysis and reporting.

    + CRP or SoCRA certification required.

    + Project or technical leadership experience required.

    + Articulate, professional and able to communicate in a clear, positive fashion with clients and staff.

    + Must be able to read, write and speak fluent English.

    + Advanced degree or its international equivalent preferred.

    + Supervisory or management experience preferred.

    + Global clinical research work preferred.

    Technology to be Used:

    + Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, etc.), e-mail, telephone, printer, calculator, copier, cell phones, PDAs and other hand held devices.

    Travel Requirements:

    + Greater than 25%

    Typical Physical Demands:

    + Typical office environment. Ability to sit and stand for extended periods of time; ability to lift 5-50 lbs.

    This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

    FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

    Please click here to continue searching FHI 360's Career Portal.

    FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research, technology, communication and social marketing — creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.

    As we evolve to meet the challenges of the future, we stand committed to the principles that have guided our organization for the last 40+ years. Our work continues to be grounded in research and science, strengthened by partnerships and focused on building the capacity of individuals, communities and countries to succeed.

    FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

    FHI 360 will never ask you for your career site username or password, and we will never request money, goods or services during the application, recruitment or employment process. If you have questions or concerns about correspondence from us, please email CareerCenterSupport@fhi360.org.


    Employment Type

    Full Time

  • Contract Sr.CRA, Oncology (Central/West Coast) - IQVIA Biotech
    IQVIA    Scottsdale, AZ 85258
     Posted 3 days    

    **IQVIA Bitoech is seeking a Contract (1099) Sr.CRA with 3-5 Years of oncology monitoring experience; Solids tumor /Phase I experience required; Gastro/colorectal cancer experience preferred.**

    **BASIC FUNCTIONS:**

    Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also serve in the Lead CRA role.

    **ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    + Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborates with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Trains site staff on the EDC system and verifies site computer system.

    + Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.

    + May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.

    + Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensures internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensures all study deliverables are completed per IQVIA Biotech and study timelines

    + Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.

    + Serves as mentor for junior CRAs and those new to the company and/or study.

    + Performs other duties, as requested.

    **LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    The Lead Clinical Research Associate **may** perform any of the following tasks:

    + Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborate with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Train site staff on the EDC system and verify site computer system.

    + Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.

    + May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM.

    + May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.

    + Assist the study management in identifying and generating changes in scope

    + Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensure all study deliverables are completed per IQVIA Biotech and study timelines

    + May conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.

    + Serve as mentor for junior CRAs and those new to the company and/or study.

    + Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.

    + Review and approve CRA travel expenses and time sheets.

    + Perform other duties, as requested.

    **TECHNICAL CTM ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    The Technical CTM **may** perform any of the following tasks for oncology studies:

    + Create master tracker(s) to house information generated from various reports such as:

    + and _CM_Data_Cleaning_Report_By_Subject_ both Business Objects reports

    + Reconcile patients that have come off treatment and off study

    + Generate and review various IL2 reports

    + Works closely with CDRC to ensure data is further reviewed and discrepancies documented.

    + The Technical CTM may participate in CDRC review and aid in Patient Profile review, as necessary.

    + There may be additional tracking required as a result of CDRC’s review.

    **KNOWLEDGE, SKILLS AND ABILITIES:**

    + Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.

    + Four+ years of oncology experience and/or medical device.

    + Experience in monitoring and/or coordinating clinical trials required.

    + Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.

    + Demonstrated ability to form strong functional relationships.

    + Excellent, presentation, organizational and interpersonal skills.

    + Ability to interact with all levels of staff to coordinate/execute study activities.

    + Ability to handle several priorities within multiple, complex trials.

    + Ability to reason independently and recommend specific solutions in clinical settings.

    + Ability to work independently, prioritize, and work within a matrix team environment.

    + Ability to mentor other CRAs and co-monitor, as required.

    + Knowledge of electronic data capture including basic data processing functions.

    + Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.

    + Able to qualify for a major credit card, rent an automobile

    + For the Technical CTM role, the CRA must have a deep understanding of IQVIA Biotech systems with the ability to learn even more.

    **PHYSICAL REQUIREMENTS:**

    + Very limited physical effort required to perform normal job duties

    + Extensive use of telephone and face-to-face communication requiring accurate perception of speech

    + Extensive use of keyboard requiring repetitive motion of fingers

    + Regular sitting for extended periods of time

    **MINIMUM RECRUITMENT STANDARDS:**

    + BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is required; or equivalent combination of education, training and experience.

    + Prior Clinical Research Organization (CRO) experience preferred.

    + Prior project team leadership experience preferred.

    + Working knowledge of budget management preferred.

    + Must be able to travel domestically and internationally approximately 65%-85%.

    + Valid driver’s license

    + Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

    \#LI-KE1

    \#CRAIBAJD

    At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

    IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

    IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

    At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.

    Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.


    Employment Type

    Full Time

  • Contract Sr.CRA, Oncology (West Coast) - IQVIA Biotech
    IQVIA    Scottsdale, AZ 85258
     Posted 3 days    

    **IQVIA Bitoech is seeking a (Contract 1099) Sr.CRA with 3-5 years of oncology monitoring experience required; at least 2 years of early phase solid tumor experience, preferably gastrointestinal cancer but nor required** .

    **BASIC FUNCTIONS:**

    Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also serve in the Lead CRA role.

    **ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    + Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborates with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Trains site staff on the EDC system and verifies site computer system.

    + Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.

    + May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.

    + Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensures internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensures all study deliverables are completed per IQVIA Biotech and study timelines

    + Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.

    + Serves as mentor for junior CRAs and those new to the company and/or study.

    + Performs other duties, as requested.

    **LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    The Lead Clinical Research Associate **may** perform any of the following tasks:

    + Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborate with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Train site staff on the EDC system and verify site computer system.

    + Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.

    + May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM.

    + May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.

    + Assist the study management in identifying and generating changes in scope

    + Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensure all study deliverables are completed per IQVIA Biotech and study timelines

    + May conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.

    + Serve as mentor for junior CRAs and those new to the company and/or study.

    + Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.

    + Review and approve CRA travel expenses and time sheets.

    + Perform other duties, as requested.

    **TECHNICAL CTM ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    The Technical CTM **may** perform any of the following tasks for oncology studies:

    + Create master tracker(s) to house information generated from various reports such as:

    + and _CM_Data_Cleaning_Report_By_Subject_ both Business Objects reports

    + Reconcile patients that have come off treatment and off study

    + Generate and review various IL2 reports

    + Works closely with CDRC to ensure data is further reviewed and discrepancies documented.

    + The Technical CTM may participate in CDRC review and aid in Patient Profile review, as necessary.

    + There may be additional tracking required as a result of CDRC’s review.

    **KNOWLEDGE, SKILLS AND ABILITIES:**

    + Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.

    + Four+ years of oncology experience and/or medical device.

    + Experience in monitoring and/or coordinating clinical trials required.

    + Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.

    + Demonstrated ability to form strong functional relationships.

    + Excellent, presentation, organizational and interpersonal skills.

    + Ability to interact with all levels of staff to coordinate/execute study activities.

    + Ability to handle several priorities within multiple, complex trials.

    + Ability to reason independently and recommend specific solutions in clinical settings.

    + Ability to work independently, prioritize, and work within a matrix team environment.

    + Ability to mentor other CRAs and co-monitor, as required.

    + Knowledge of electronic data capture including basic data processing functions.

    + Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.

    + Able to qualify for a major credit card, rent an automobile

    + For the Technical CTM role, the CRA must have a deep understanding of IQVIA Biotech systems with the ability to learn even more.

    **PHYSICAL REQUIREMENTS:**

    + Very limited physical effort required to perform normal job duties

    + Extensive use of telephone and face-to-face communication requiring accurate perception of speech

    + Extensive use of keyboard requiring repetitive motion of fingers

    + Regular sitting for extended periods of time

    **MINIMUM RECRUITMENT STANDARDS:**

    + BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is required; or equivalent combination of education, training and experience.

    + Prior Clinical Research Organization (CRO) experience preferred.

    + Prior project team leadership experience preferred.

    + Working knowledge of budget management preferred.

    + Must be able to travel domestically and internationally approximately 65%-85%.

    + Valid driver’s license

    + Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

    \#LI-KE1

    \#CRAIBAJD

    At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

    IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

    IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

    At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.

    Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.


    Employment Type

    Full Time

  • Contract Sr.CRA, Oncology, (West Coast) - IQVIA Biotech
    IQVIA    Scottsdale, AZ 85258
     Posted 3 days    

    IQVIA Biotech is seeking a contract Sr.CRA 3-5+ years of oncology monitoring experience required; at least 2 years of early phase solid tumor experience, preferably gastrointestinal cancer but not required.

    **BASIC FUNCTIONS:**

    Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also serve in the Lead CRA role.

    **ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    + Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborates with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Trains site staff on the EDC system and verifies site computer system.

    + Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.

    + May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.

    + Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensures internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensures all study deliverables are completed per IQVIA Biotech and study timelines

    + Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.

    + Serves as mentor for junior CRAs and those new to the company and/or study.

    + Performs other duties, as requested.

    **LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    The Lead Clinical Research Associate **may** perform any of the following tasks:

    + Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborate with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Train site staff on the EDC system and verify site computer system.

    + Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.

    + May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM.

    + May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.

    + Assist the study management in identifying and generating changes in scope

    + Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensure all study deliverables are completed per IQVIA Biotech and study timelines

    + May conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.

    + Serve as mentor for junior CRAs and those new to the company and/or study.

    + Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.

    + Review and approve CRA travel expenses and time sheets.

    + Perform other duties, as requested.

    **TECHNICAL CTM ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    The Technical CTM **may** perform any of the following tasks for oncology studies:

    + Create master tracker(s) to house information generated from various reports such as:

    + and _CM_Data_Cleaning_Report_By_Subject_ both Business Objects reports

    + Reconcile patients that have come off treatment and off study

    + Generate and review various IL2 reports

    + Works closely with CDRC to ensure data is further reviewed and discrepancies documented.

    + The Technical CTM may participate in CDRC review and aid in Patient Profile review, as necessary.

    + There may be additional tracking required as a result of CDRC’s review.

    **KNOWLEDGE, SKILLS AND ABILITIES:**

    + Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.

    + Four+ years of oncology experience and/or medical device.

    + Experience in monitoring and/or coordinating clinical trials required.

    + Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.

    + Demonstrated ability to form strong functional relationships.

    + Excellent, presentation, organizational and interpersonal skills.

    + Ability to interact with all levels of staff to coordinate/execute study activities.

    + Ability to handle several priorities within multiple, complex trials.

    + Ability to reason independently and recommend specific solutions in clinical settings.

    + Ability to work independently, prioritize, and work within a matrix team environment.

    + Ability to mentor other CRAs and co-monitor, as required.

    + Knowledge of electronic data capture including basic data processing functions.

    + Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.

    + Able to qualify for a major credit card, rent an automobile

    + For the Technical CTM role, the CRA must have a deep understanding of IQVIA Biotech systems with the ability to learn even more.

    **PHYSICAL REQUIREMENTS:**

    + Very limited physical effort required to perform normal job duties

    + Extensive use of telephone and face-to-face communication requiring accurate perception of speech

    + Extensive use of keyboard requiring repetitive motion of fingers

    + Regular sitting for extended periods of time

    **MINIMUM RECRUITMENT STANDARDS:**

    + BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is required; or equivalent combination of education, training and experience.

    + Prior Clinical Research Organization (CRO) experience preferred.

    + Prior project team leadership experience preferred.

    + Working knowledge of budget management preferred.

    + Must be able to travel domestically and internationally approximately 65%-85%.

    + Valid driver’s license

    + Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

    \#LI-KE

    \#CRAIBAJD

    At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

    IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

    IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

    At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.

    Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.


    Employment Type

    Full Time

  • Contract Sr.CRA, Oncology (West Coast) - IQVIA Biotech
    IQVIA    Tucson, AZ 85702
     Posted 3 days    

    **IQVIA Bitoech is seeking a (Contract 1099) Sr.CRA with 3-5 years of oncology monitoring experience required; at least 2 years of early phase solid tumor experience, preferably gastrointestinal cancer but nor required** .

    **BASIC FUNCTIONS:**

    Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also serve in the Lead CRA role.

    **ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    + Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborates with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Trains site staff on the EDC system and verifies site computer system.

    + Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.

    + May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.

    + Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensures internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensures all study deliverables are completed per IQVIA Biotech and study timelines

    + Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.

    + Serves as mentor for junior CRAs and those new to the company and/or study.

    + Performs other duties, as requested.

    **LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    The Lead Clinical Research Associate **may** perform any of the following tasks:

    + Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborate with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Train site staff on the EDC system and verify site computer system.

    + Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.

    + May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM.

    + May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.

    + Assist the study management in identifying and generating changes in scope

    + Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensure all study deliverables are completed per IQVIA Biotech and study timelines

    + May conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.

    + Serve as mentor for junior CRAs and those new to the company and/or study.

    + Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.

    + Review and approve CRA travel expenses and time sheets.

    + Perform other duties, as requested.

    **TECHNICAL CTM ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    The Technical CTM **may** perform any of the following tasks for oncology studies:

    + Create master tracker(s) to house information generated from various reports such as:

    + and _CM_Data_Cleaning_Report_By_Subject_ both Business Objects reports

    + Reconcile patients that have come off treatment and off study

    + Generate and review various IL2 reports

    + Works closely with CDRC to ensure data is further reviewed and discrepancies documented.

    + The Technical CTM may participate in CDRC review and aid in Patient Profile review, as necessary.

    + There may be additional tracking required as a result of CDRC’s review.

    **KNOWLEDGE, SKILLS AND ABILITIES:**

    + Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.

    + Four+ years of oncology experience and/or medical device.

    + Experience in monitoring and/or coordinating clinical trials required.

    + Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.

    + Demonstrated ability to form strong functional relationships.

    + Excellent, presentation, organizational and interpersonal skills.

    + Ability to interact with all levels of staff to coordinate/execute study activities.

    + Ability to handle several priorities within multiple, complex trials.

    + Ability to reason independently and recommend specific solutions in clinical settings.

    + Ability to work independently, prioritize, and work within a matrix team environment.

    + Ability to mentor other CRAs and co-monitor, as required.

    + Knowledge of electronic data capture including basic data processing functions.

    + Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.

    + Able to qualify for a major credit card, rent an automobile

    + For the Technical CTM role, the CRA must have a deep understanding of IQVIA Biotech systems with the ability to learn even more.

    **PHYSICAL REQUIREMENTS:**

    + Very limited physical effort required to perform normal job duties

    + Extensive use of telephone and face-to-face communication requiring accurate perception of speech

    + Extensive use of keyboard requiring repetitive motion of fingers

    + Regular sitting for extended periods of time

    **MINIMUM RECRUITMENT STANDARDS:**

    + BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is required; or equivalent combination of education, training and experience.

    + Prior Clinical Research Organization (CRO) experience preferred.

    + Prior project team leadership experience preferred.

    + Working knowledge of budget management preferred.

    + Must be able to travel domestically and internationally approximately 65%-85%.

    + Valid driver’s license

    + Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

    \#LI-KE1

    \#CRAIBAJD

    At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

    IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

    IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

    At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.

    Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.


    Employment Type

    Full Time

  • Contract Sr.CRA, Oncology, (West Coast) - IQVIA Biotech
    IQVIA    Tucson, AZ 85702
     Posted 3 days    

    IQVIA Biotech is seeking a contract Sr.CRA 3-5+ years of oncology monitoring experience required; at least 2 years of early phase solid tumor experience, preferably gastrointestinal cancer but not required.

    **BASIC FUNCTIONS:**

    Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also serve in the Lead CRA role.

    **ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    + Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborates with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Trains site staff on the EDC system and verifies site computer system.

    + Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.

    + May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.

    + Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensures internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensures all study deliverables are completed per IQVIA Biotech and study timelines

    + Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.

    + Serves as mentor for junior CRAs and those new to the company and/or study.

    + Performs other duties, as requested.

    **LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    The Lead Clinical Research Associate **may** perform any of the following tasks:

    + Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborate with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Train site staff on the EDC system and verify site computer system.

    + Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.

    + May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM.

    + May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.

    + Assist the study management in identifying and generating changes in scope

    + Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensure all study deliverables are completed per IQVIA Biotech and study timelines

    + May conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.

    + Serve as mentor for junior CRAs and those new to the company and/or study.

    + Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.

    + Review and approve CRA travel expenses and time sheets.

    + Perform other duties, as requested.

    **TECHNICAL CTM ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    The Technical CTM **may** perform any of the following tasks for oncology studies:

    + Create master tracker(s) to house information generated from various reports such as:

    + and _CM_Data_Cleaning_Report_By_Subject_ both Business Objects reports

    + Reconcile patients that have come off treatment and off study

    + Generate and review various IL2 reports

    + Works closely with CDRC to ensure data is further reviewed and discrepancies documented.

    + The Technical CTM may participate in CDRC review and aid in Patient Profile review, as necessary.

    + There may be additional tracking required as a result of CDRC’s review.

    **KNOWLEDGE, SKILLS AND ABILITIES:**

    + Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.

    + Four+ years of oncology experience and/or medical device.

    + Experience in monitoring and/or coordinating clinical trials required.

    + Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.

    + Demonstrated ability to form strong functional relationships.

    + Excellent, presentation, organizational and interpersonal skills.

    + Ability to interact with all levels of staff to coordinate/execute study activities.

    + Ability to handle several priorities within multiple, complex trials.

    + Ability to reason independently and recommend specific solutions in clinical settings.

    + Ability to work independently, prioritize, and work within a matrix team environment.

    + Ability to mentor other CRAs and co-monitor, as required.

    + Knowledge of electronic data capture including basic data processing functions.

    + Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.

    + Able to qualify for a major credit card, rent an automobile

    + For the Technical CTM role, the CRA must have a deep understanding of IQVIA Biotech systems with the ability to learn even more.

    **PHYSICAL REQUIREMENTS:**

    + Very limited physical effort required to perform normal job duties

    + Extensive use of telephone and face-to-face communication requiring accurate perception of speech

    + Extensive use of keyboard requiring repetitive motion of fingers

    + Regular sitting for extended periods of time

    **MINIMUM RECRUITMENT STANDARDS:**

    + BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is required; or equivalent combination of education, training and experience.

    + Prior Clinical Research Organization (CRO) experience preferred.

    + Prior project team leadership experience preferred.

    + Working knowledge of budget management preferred.

    + Must be able to travel domestically and internationally approximately 65%-85%.

    + Valid driver’s license

    + Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

    \#LI-KE

    \#CRAIBAJD

    At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

    IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

    IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

    At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.

    Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.


    Employment Type

    Full Time

  • Contract Sr.CRA, Oncology (Central/West Coast) - IQVIA Biotech
    IQVIA    Tucson, AZ 85702
     Posted 3 days    

    **IQVIA Bitoech is seeking a Contract (1099) Sr.CRA with 3-5 Years of oncology monitoring experience; Solids tumor /Phase I experience required; Gastro/colorectal cancer experience preferred.**

    **BASIC FUNCTIONS:**

    Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also serve in the Lead CRA role.

    **ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    + Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborates with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Trains site staff on the EDC system and verifies site computer system.

    + Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.

    + May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.

    + Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensures internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensures all study deliverables are completed per IQVIA Biotech and study timelines

    + Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.

    + Serves as mentor for junior CRAs and those new to the company and/or study.

    + Performs other duties, as requested.

    **LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    The Lead Clinical Research Associate **may** perform any of the following tasks:

    + Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborate with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Train site staff on the EDC system and verify site computer system.

    + Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.

    + May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM.

    + May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.

    + Assist the study management in identifying and generating changes in scope

    + Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensure all study deliverables are completed per IQVIA Biotech and study timelines

    + May conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.

    + Serve as mentor for junior CRAs and those new to the company and/or study.

    + Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.

    + Review and approve CRA travel expenses and time sheets.

    + Perform other duties, as requested.

    **TECHNICAL CTM ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    The Technical CTM **may** perform any of the following tasks for oncology studies:

    + Create master tracker(s) to house information generated from various reports such as:

    + and _CM_Data_Cleaning_Report_By_Subject_ both Business Objects reports

    + Reconcile patients that have come off treatment and off study

    + Generate and review various IL2 reports

    + Works closely with CDRC to ensure data is further reviewed and discrepancies documented.

    + The Technical CTM may participate in CDRC review and aid in Patient Profile review, as necessary.

    + There may be additional tracking required as a result of CDRC’s review.

    **KNOWLEDGE, SKILLS AND ABILITIES:**

    + Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.

    + Four+ years of oncology experience and/or medical device.

    + Experience in monitoring and/or coordinating clinical trials required.

    + Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.

    + Demonstrated ability to form strong functional relationships.

    + Excellent, presentation, organizational and interpersonal skills.

    + Ability to interact with all levels of staff to coordinate/execute study activities.

    + Ability to handle several priorities within multiple, complex trials.

    + Ability to reason independently and recommend specific solutions in clinical settings.

    + Ability to work independently, prioritize, and work within a matrix team environment.

    + Ability to mentor other CRAs and co-monitor, as required.

    + Knowledge of electronic data capture including basic data processing functions.

    + Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.

    + Able to qualify for a major credit card, rent an automobile

    + For the Technical CTM role, the CRA must have a deep understanding of IQVIA Biotech systems with the ability to learn even more.

    **PHYSICAL REQUIREMENTS:**

    + Very limited physical effort required to perform normal job duties

    + Extensive use of telephone and face-to-face communication requiring accurate perception of speech

    + Extensive use of keyboard requiring repetitive motion of fingers

    + Regular sitting for extended periods of time

    **MINIMUM RECRUITMENT STANDARDS:**

    + BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is required; or equivalent combination of education, training and experience.

    + Prior Clinical Research Organization (CRO) experience preferred.

    + Prior project team leadership experience preferred.

    + Working knowledge of budget management preferred.

    + Must be able to travel domestically and internationally approximately 65%-85%.

    + Valid driver’s license

    + Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

    \#LI-KE1

    \#CRAIBAJD

    At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

    IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

    IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

    At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.

    Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.


    Employment Type

    Full Time


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