Clinical Trials Site Coordinator
2 tygodni temu
Job Responsibilities
As a Clinical Trials Site Coordinator at PSI, you will be the primary point of contact between the Sponsor, CRO, and medical institution, building strong relationships with medical staff and Sponsor representatives.
Key Responsibilities
- Act as the main line of communication between the Sponsor, CRO, and medical institution.
- Build and maintain good rapport with medical staff and Sponsor representatives involved in clinical trials.
- Facilitate the evaluation of proposed studies and ensure timely responses to feasibility questions.
- Assist in scheduling, preparation, and conduct of monitoring visits at the medical institution.
- Actively participate in monitoring visits and track enrollment to ensure targets are met.
- Maintain study-specific and general tracking documents at the site level.
- Ensure accurate and timely data entry into EDC systems and resolve data clarification queries.
- Support timely reporting and follow-up on Adverse Events, Serious Adverse Events, and Protocol Deviations.
- Properly handle, account for, and reconcile investigational products and clinical supplies.
- Collect and maintain site-specific documents for submission to authorities.
- Facilitate and support contract and budget negotiations at the site level.
- Oversee and manage Investigator and Site payments.
- Ensure the medical site team completes necessary training before involvement in clinical trials.
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