Principal Investigator

Role & responsibilities

• Ensure that all human-subjects research is conducted in an ethical manner and in accordance with all federal, state, and local laws and regulations and institutional policies.
• Ensuring that a clinical study is personally conducted and supervised in compliance with GCP, with the applicable regulatory requirement(s), with the protocol agreed to by the sponsor and given approval/favorable opinion by the EC and as per in house SOP.
• Supervision and overall responsibility of all studies from end to end.
• Significant contribution in design and development of SOPs for clinical research BA/BE studies.
• Delegation of study specific activities to study personnel.
• Imparting training to study personnel for study specific protocols.
• Interaction with Ethics committee regarding protocol submission, presentation of protocol to the ethics committee and obtaining approval for the protocols.
• Screening, Physical examination and selection of the healthy volunteers.
• Screening and selection of the healthy volunteers.
• Presentation and obtaining screening/study specific ICF and clarify the questions.
• Vital signs examination during study and check-in process.
• Management of AE and SAE.
• Apply Inclusion/Exclusion criteria for selection of healthy subjects for the study.
• Monitoring the entire study process.
• Post study report analysis, documentation, follow up.
• IP receipt, Accountability, dispensing, archival and retrieval.
• Various Regulatory Compliance.
• In charge of all clinical logbooks.
• CAPA Response to QA/Sponsors observation / queries.
• Personally, conducting or supervising the conduct of human-subjects research and for protecting the rights, safety, and welfare of the subjects enrolled in the research in compliance to GCP.
• Facing various regulatory/Sponsor audit
• Ensure clinical studies are conducted as per agreed timeline and meet customer satisfaction

Preferred candidate profile

MBBS or MD Pharmacology qualification with relevant experience in conducting BA/BE studies.