Principle Investigator in Kandla

We are looking candidate for Principal Investigator.

Job Location : Kandla

Experience : Min 5 years as Principle Investigator

Qualification : MBBS / MD Pharmacology

Job Responsibility :

• 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.
• Planning of Projects & effective utilization of existing resources for timely execution of projects.
• Delegate responsibilities and monitor the performance of directly reporting staff.
• Introspect and implement review mechanisms to minimize observations. Encourage and perform online documentation of study related CRFs and documents to meet the project timelines.
• Co-ordinate internal and external audits/ inspections.
• Resolution of Ethical, Medical and/or Technical queries from Ethics Committee / Sponsor / Regulatory agency in appropriately and adequately while maintaining a thorough documentation of the same.
• Conduct of internal post study review meetings to discuss problems and issues faced in earlier studies and develop solutions to prevent reoccurrence of such issues.
• Allocation of resources to pilot and pivotal studies and ensuring their completion as per project timelines.
• Ensure that clinics are occupied to maximum extent by prudent planning of studies. Ensure that all activities are carried out under complete regulatory/ SOP/ Protocol compliance.
• Ensure that observations made during various audits and study monitoring are implemented immediately and adequately responded to and team members trained and counseled adequately to avoid repetition of mistakes.
• Ensure that equipments and instruments in the scope of clinical operations are qualified and records well maintained at all times.
• Ensure that all other records and documents coming under the scope of clinical operations are up to date and well maintained.
• Ensure timely and archival of documents of completed studies/ logbooks, X-rays etc and other clinical documents.
• Identify the training needs of the team members and provide prompt training.
• Provide scientific, medical, technical & design inputs during protocol, ICF, CRFs preparation with appropriate reasoning.
• Provide timely clinical safety and feasibility of conducting projects as and when feasibility is requested for by the project management team.
• Screening of volunteers and verifying laboratory results of screened volunteers for determining eligibility of volunteers for study participation.

Additional Responsibilities

Additional responsibilities may be assigned from time to time.