Clinical Research Associate Responsibilities:
- Creating and writing trial protocols, and presenting these to the steering committee.
- Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.
- Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
- Liaise with the ethics committee regarding the rights, safety (EXPERIENCE), and well-being of trial subjects.
- Ordering, tracking, and managing IP and trial materials.
- Overseeing and documenting IP dispensing inventory, and reconciliation.
- Protecting subjects' confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.
- Conducting regular site visits, coordinating project meetings, and writing visit reports.
- Implementing action plans for sites not meeting expectations.
- Liaising with regulatory authorities.
- Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
- Other tasks and responsibilities as needed.