• 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.