Principal Investigator
16 hours ago
Role & responsibilities
Act as a Principal Investigator / Co-investigator in phase-1 studies, Biosimilar and BA/BE studies in all therapeutic area as well as various kind of formulation.
Feasibility assessment of different molecules as per request from sponsors.
Conducted complex BA/BE study at hospital site as Principal Investigator.
Involved in Audit/Inspection handling and Projects conducted as Principal Investigator have been audited and cleared by different regulatory.
Leading and guiding the Research Staff as Team Lead.
Prepare and review protocols for clinical studies
Ensure compliance to protocol, SOPs and Regulatory requirements
Communicate IEC related issues to all concerned
Coordinate with Project Coordinators for all project related matters
Monitor and manage adverse events
Coordinate with panel of consultants to seek medical opinion as and when required
Ensure timely response to QA findings
Interact with sponsors on medical related matters
Handle safety related issues and ensure appropriate communication
Prepare and review reports for clinical studies
Overall supervision of screening and check-in activities
Write and review related SOPs
Contribute towards scientific development of the organization
Support clinical trial group
Handle medical confidential report and case management
Help maintain and update all the systems and SOPs in the department
Train the staff on CPR, GCP and related guidelines and all departmental and relevant SOPs.
Any other responsibilities as assigned by the Head of the Department
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