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gcp monitoring edc informed consent site management📋 Description
- Oversees all aspects of study site management to protect patient safety and data quality.
- Guides audit readiness and supports audit preparation and follow-up actions.
- Manages site startup: feasibility, investigator recruitment, EC/IRB submissions, and docs.
- Conducts on-site and remote monitoring visits per protocol; prepares monitoring reports.
- Ensures data integrity via IP inventory, data review, TMF/ISF reconciliation, SAE processing.
- Mentors junior staff and collaborates with Clinical Trial Management.
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