Position: Principal Investigators
Exp: 2-4 yrs
Education: MBBS, MD Pharmacology
- As Principal Investigator, responsible for conducting BA/BE Studies and Regulatory Submission (ANDA) for various Pharma clients.
- Review of Protocols, ICFs, CRFs and other study related documents; providing inputs to the “Study protocol” and obtain approvals from IEC and Regulatory Authorities.
- Training all Study Personnel on relevant areas of Protocol; ensuring adequate facilities including management/maintenance of ICU equipment/instruments.
- Verification of Registration documents for completion of the study.
- Medical Examination of volunteers at screening or during the study. Selection or rejection of subjects based on study requirements. Providing Medical Care to the subjects during and after the study. Management and reporting of AE / SAEs.
- Review of study reports | Facing Audits on the conduct of the study and completion of the study | Prepare and review related SOPs | Communicate and interact effectively with all stakeholders.