- Supports the Clinical Operations team in study execution and may act as the central contact for project communication and documentation.
- Attends the study team meetings, takes, and distributes meeting minutes.
- Maintains and generates appropriate study tracking sheets (e.g., patient enrollment and IRB approvals).
- Ensures Inspection Readiness by managing the set-up, maintenance, and quality control of the Trial Master Files and supports oversight of the CRO's management of Trial Master Files.
- Manages the Clinical Operational internal document filing system and documents.
- Not initially but may eventually train more junior CTA staff and act as lead for work performed by CTA staff.
- Performs other responsibilities as assigned.
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