Sr CRA - oncology (Poland, Warsaw or Cracow)
Main responsibilities include but are not limited to:
- Critically evaluates adequacy of investigator sites (qualifications, facilities, equipment and performance). Performs all tasks required for onsite/remote monitoring including but not limited to source document review (SDR) and source document verification (SDV).
- Completes and submits monitoring visit reports in accordance with SOP/Work Instructions or Sponsor requirements as agreed in the scope of work.
- Ensures all assigned sites are fully trained.
- Extensive travel may be required, 50% to 75% on a regular basis.
- Maintains site performance metrics and implements action plans for sites not meeting expectations with minimal guidance.
- Maintains up to date information within the deployed CTMS.
2. Reporting and Tracking
3. Data Management— Uses analytical thinking to review data recorded in source documents for accuracy and completeness, and in accordance with the clinical monitoring and associated plans. Verifies that the clinical data entered in the case report form (CRF) is accurate and complete.
4. Investigational Product—Performs IP inventory, reconciliation and reviews storage and security. Verifies that the IP has been dispensed and administered to subjects according to the protocol. Verifies process and identifies any issues or risks associated with blinded or randomized information related to IP.
5. Documentation and Record keeping— Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with that of the trial master file (TMF
6. Communication—Maintains effective, accurate, and timely communication with site staff and project team, ensures appropriate issue escalation.
7. Attends clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements
8. May provide training or mentorship to more junior-level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.