Clinical Trials (Chennai)

JOB DETAILS

1.Creating and writing trial protocols, and presenting these to steering committee.

2.Identifying, evaluating and establishing trial sites, and closing sites down on completion of trial.

3.Training site staff on therapeutic areas, protocol requirements, proper source documentation and case report form completion.

4.Liaise with ethics committee regarding rights, safety and well-being of trial subjects.

5.Ordering, tracking, and managing IP and trial materials.

6.Overseeing and documenting IP dispensing, inventory and reconciliation.

7.Protecting subjects confidentiality, updating their information, and verifying IP has been dispensed and administered according to protocol.

8.Conducting regular site visits, coordinating project meetings and writing visit reports.

9.Implementing action plans for sites not meeting expectations.

10.Liaising with regulatory authorities.

11.Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.

12.Other tasks and responsibilities as needed.

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