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Senior Clinical Trial Associate
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Full-time
- Ensures study compliance with OPUS SOPs and regulatory guidelines.
- Ensures TMF/eTMF is FDinspection ready at all times while the clinical trial is being conducted.
- Tracks study progress including site contracts, patient enrolment and patient status, and provides QC oversight of the CRO, TMF, QV Reports, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines.
- Contributes to the 3rd party vendor qualification process (e.g. getting their financial condition utilizing a specific vendor, checking if there is an unacceptable risk of bribery or corruption using a specific checklist).
- Ensures study compliance with OPUS SOPs and regulatory guidelines by performing periodic quality control audits of any trial master file (TMF) maintained by the Service Provider (SP) before study initiation, during and at the end of a study.
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