Job Overview
Durham, United States of America | Full time | Field-based | R
IQVIA is seeking a CRA 2 with a minimum of 1.5 years of on-site oncology monitoring experience:
This role focuses on in‑site monitoring of oncology clinical trials, ensuring adherence to Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and contractual scope of work.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close‑out) per contractual scope and regulatory requirements.
- Work with sites to adapt, drive, and track subject recruitment plans to meet project needs.
- Administer protocol and related study training to assigned sites and maintain regular communication with sites to manage project expectations and issues.
- Evaluate the quality and integrity of study site practices, ensuring proper conduct of the protocol and adherence to applicable regulations; escalates quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution; may support the start‑up phase.
- Ensure copies or originals of required site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator’s Site File (ISF) complies with GCP and local regulatory requirements.
- Create and maintain documentation of site management, monitoring visit findings, and action plans by submitting regular visit reports, generating follow‑up letters, and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting the development of project subject recruitment plan on a per‑site basis.
- If applicable, may be accountable for site financial management per the clinical trial agreement and retrieve invoices according to local requirements.
Qualifications
- Education: Bachelor’s Degree in a scientific discipline or health care preferred.
- Experience: 1.5 to 2 years of relevant CRA experience, including on‑site monitoring in oncology.
Compensation
The potential base pay range for this role, when annualized, is $87,200.00 – $145,300.00. Actual compensation may vary based on qualifications, location, schedule, and other factors. Incentive plans, bonuses, and additional compensation may be offered along with a range of health and welfare benefits.
Equal Opportunity Employer
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. EEO Statement
Integrity Policy
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted must be truthful and complete. False statements, misrepresentations, or material omissions will result in immediate disqualification or, if discovered later, termination, in accordance with applicable law.
Location
Durham, United States of America
Employment Type
Field‑based, Full time
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