Medical Officer

Role & responsibilities

1. Follow the Declaration of Helsinki, ICH guidelines and GCP in executing the studies.

2. Build procedures and ensuring compliance with established guidelines.

3. Ensuring that the BA / BE Studies are conducted adherence with Protocol, SOP,

GCP, GLP and applicable regulatory requirements

4. Introduce process improvements/controls to reduce wastages and enhance overall

operational economy.

5. Interact with sponsors and provide valuable inputs to the sponsors regarding

tactical and strategic issues

6. Efficiently and effectively handling their regulatory and client audits

7. Render High level support to management in making important decisions for

smooth running of the business.

8. Participate in business development, planning & Development future expansion

and service diversification of CRO

9. Responsible to take decision of outcome of trials.

10. Coordinate with project coordinators for all projects related information.

11. Attend to sponsor queries related to study protocols, amendments, reports and raw data.

12. Coordinate with auditors for facility audit, process audit and study audit inspections.

13. Responsible for CAPA response to facility audit, process audit, Study Audit and

Online Documentation.

14. Responsible for planning and scheduling activities as per study plan.

15. Responsible for ensuring the obtaining approval of trail protocols .Informed

consent form and other related documents from EC.

16. Responsible for monitoring Study activities.

17. Responsible to ensure that all personnel involved in the clinical study are

adequately and trained on SOPs, internal process as defined.

18. Ensure that all study participants give consent voluntarily, to participate in the study.

19. Responsibility for counselling of subjects and obtaining informed consent

document for participation in study.

20. Responsibility of maintain confidentiality of study subjects.