CRA 2, Oncology, IQVIA
$87,200–$145,300 year
On-siteDurham, North Carolina, United States
Job Summary
Conduct site monitoring visits, including selection, initiation, and close-out, adhering to Good Clinical Practice and ICH guidelines. Adapt and track subject recruitment plans to enhance predictability while administering protocol training and establishing communication lines with sites. Evaluate site practices for protocol adherence and regulatory compliance, escalating quality issues as needed. Manage study progress by tracking regulatory submissions, enrollment, CRF completion, and data query resolution. Ensure site documents are filed in the Trial Master File and Investigator's Site File. Submit regular visit reports, generate follow-up letters, and collaborate with the study team for execution support. Manage site financials and invoice retrieval where applicable. Requires 1.5 years of oncology CRA experience with a Bachelor's degree. Base pay ranges from $87,200 to $145,300 annually.
Required Qualifications
- 1.5 years of on-site oncology monitoring experience
- 1.5 to 2 years of relevant CRA experience including on-site monitoring
- Bachelor's Degree
- Good Clinical Practice (GCP)
- International Conference on Harmonization (ICH) guidelines
- Knowledge of regulatory requirements
- Knowledge of Good Clinical Practice (GCP)
- Knowledge of local regulatory requirements
Desired Qualifications
- Degree in scientific discipline
- Degree in health care
- Experience supporting start-up phase
- Accountability for supporting development of project subject recruitment plan on a per site basis
- Accountability for site financial management
- Ability to retrieve invoices according to local requirement
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