Sub-Investigator

Job Description

Position Title- Sub-Investigator

Department- Clinical Affairs

Experience Requirement: 2-3 years of experience in handling clinical study activities.

Qualification Requirement: MBBS/MD.

Profile Requirements:

1. Support the Principal Investigator in the conduct of clinical studies in accordance with the approved protocol, amendments, and applicable SOPs.

2. Perform study-related medical activities delegated by the PI and Ensure that delegated activities are performed only within the individual's qualifications, training, experience, and medical scope of practice.

3. Review participant eligibility and relevant medical information as delegated by the PI.

4. Conduct or support medical assessments, physical examinations, and other protocol-required clinical procedures.

5. Monitor participants for clinical signs, symptoms, adverse events, and other safety concerns. Promptly inform the PI of significant medical findings, adverse events, protocol deviations, and other safety concerns.

6. Ensure appropriate medical evaluation, management, and follow-up of participants, as required.

7. Ensure appropriate medical intervention and referral where required.

8. Support emergency medical management and ensure appropriate escalation in accordance with the study protocol and site procedures.

9. Maintain participant confidentiality and protect personal and medical information.

10. Support the PI in the informed consent process and Ensure that informed consent is obtained before performing study-specific procedures.

11. Provide participants with adequate information regarding study procedures, risks, benefits, alternatives, and applicable requirements within the scope of the approved consent process.

12. Ensure accurate, complete, contemporaneous, and traceable documentation of delegated activities.

13. Ensure consistency between source documents and CRFs/eCRFs for information under the Sub-Investigator's responsibility.

14. Review and respond to data queries within defined timelines. Ensure that corrections to records are made in accordance with Good Documentation Practice and data integrity principles.

15. Ensure that no study-specific procedure is performed outside the approved protocol unless necessary to eliminate an immediate hazard to a participant

16. Participate in protocol and study-specific training before performing delegated study activities.

17. Support review and interpretation of laboratory and other clinically relevant investigation results, where applicable.

18. Support appropriate administration/use, monitoring, and accountability of investigational products as delegated and applicable to the study.

19. Support preparation and submission of safety reports to the Sponsor, Ethics Committee and regulatory authorities, as applicable and as delegated.

20. Maintain compliance with applicable regulatory requirements, including ICH-GCP, NDCTR 2019, CDSCO requirements, and applicable institutional requirements.

21. Support the PI during sponsor monitoring, audits, and regulatory inspections.