CRC - Protocol Writing

Role & responsibilities

1.Responsible for literature survey for preparation of synopsis and protocols as per

applicable regulatory guidelines.

2. Preparation of synopsis for biostudy protocol.

3. Prepare and finalize the biostudy protocols based upon synopsis as per the SOP

and requirement.

4. Coordinate with investigators for finalization of protocol

5. Responsible for responding to sponsor queries on time as per the internal

procedure.

6. Preparation of protocol amendments.

7. Keeping the respective documents updated for regulatory submission.

8. Responsible for SOP revisions, con-ections & implementation (in liaison with QA)

9. Coordinating with other departments like clinical, bioanalytical and quality

assurance department to ensure the smooth workflow.

10. Responsible for preparation, correcction, revision and implementation of standard

operating procedure in liaison with QA.

Preferred candidate profile

Doctorate or Master's

Perks and benefits