Position - Principal Investigator / Investigator
Department - Clinical
Job Location - Gandhidham, Kutch, Gujarat
Qualification Required - MD Pharmacology / MBBS
Roles and Responsibilities:
1. Review and Writing of SOPs.
2. Evaluating of clinical feasibility for conducting BE and Clinical studies for Sponsor interested molecules.
3. Propose/ review study designs in line with study objectives, applicable guidelines and safety of study subjects. Reviewing and finalizing Protocol, ICFs and CRFs and check whether the same is complying with the regulatory requirements. Provide scientific, medical, and technical & design inputs during protocol, ICF, CRFs preparation with appropriate reasoning and literature referencing.
4. Planning of the department budget and monitoring actual expenditure versus budget.
5. 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.
6. Obtaining the sponsor signatures, finalizing other study related documents, and making the IEC submission for getting timely approvals from the IEC. Follow up with IEC for early and timely approvals or query resolutions.
7. Receiving Investigational products from the sponsor after approval of Protocol by the IEC and the DCGI.
8. Oversee day-to-day operations of the department.
9. Implement quality system within the department to comply with regulatory/ statutory requirements and in line with applicable GxP.
10. Facilitate timely scheduling of Ethics committee meetings for project approvals and ensure that all queries raised by the committee for project approval are promptly and satisfactorily responded to, with appropriate documentation of the same and submitted in time for approval.
Interested Candidate can share their CV at email : info@quantysclinical.com
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