- Conduct regular monitoring visits to ensure protocol compliance and subject safety.
- Perform Source Document Verification (SDV) for data accuracy.
- Maintain electronic and/or paper Trial Master File (TMF) documentation.
- Manage and oversee study-related vendors and CRO activities.
- Review vendor contracts, Statements of Work (SOWs), and invoices.
- Manage investigational products and review protocol deviations.
- Support training activities for clinical research teams and site staff.
- Provide on-site assistance and guidance to trial centers for execution of Photoimmunotherapy (PIT).
GCP