Principal Investigator

Role & responsibilities

• Planning of the department budget and monitoring actual expenditure versus budget.
• Preparing the study plan for the month and quarter, in discussion with unit head along with stand-by plan in case of any unexpected changes to the original plan.
• Oversee day to day operations of the department.
• Implement quality systems within the department to comply with regulatory/ statutory requirements and in line with international GLP practices.
• Facilitate timely scheduling of Ethics committee meetings for project approvals and ensure that all queries raised by the committee for project approval are promptly responded to, with appropriate documentation of the same and submitted in time for approval.
• Review and authorize procedures & study related documents.
• Introspect and implement review mechanisms io minimize observations. Encourage and perform online documentation of study related CRFs and documents to meet the project timelines

Preferred candidate profile

• M. Pharm/ MBBS/ BHMS degree
• 2-7 years of experience in clinical investigation.
• Strong understanding of clinical trials regulations (FDA), ICH guidelines, GCP principles, and Good Clinical Practice (GCP).