ICBio Principal Investigator Job – Clinical Research India
ICBio Clinical Research, a leading Contract Research Organization (CRO), is inviting applications for the position of Principal Investigator. This is a remarkable opportunity for qualified professionals (MBBS/MD) to lead clinical research operations, oversee bioequivalence studies, and ensure regulatory compliance. If you’re passionate about shaping the future of clinical trials, this role could be your next big step.
About ICBio Clinical Research: CRO
ICBio Clinical Research is a Contract Research Organization (CRO) dedicated to advancing clinical research and medical affairs. We are committed to conducting high-quality studies in compliance with regulatory standards and guidelines.
Job Posting: Principal Investigator
About the job
- Role and Responsibility:
- Overall management of the Clinical Research & Medical Affairs department. Ensures timely execution of clinical studies in conformance to GCP, ICH guidelines and regulatory requirements.
- Review of study-related documents such as protocol, IB, CRF, Informed consent documents, study report, Raw data, and CRF compilation. Preparation, review, approval of clinical SOPs, and their implementation.
- Screening, selection of volunteers, obtaining informed consent for study participation, and study conduct conforming with protocol.
- Manage and report AE & SAE and treat medical emergencies. Supervising the activities carried out by other clinical team/ staff, and facility management.
- Staff assessment and identification of areas where staff needs higher/ regular training to the staff on GCP /GLP/ SOPs Communication with EC, biostatistician and Sponsor on study updates.
- Coordinating with Clinical, Bioanalytical, and Pharmacokinetic & Bio-Statistical investigators for the timely completion of the studies. Supervision of planning, scheduling, and execution of BA/BE studies for timely commencement, conduct and conclusion of the projects.
- Responsibility of investigational drug products, including receipt, dispensing, and accountability.
Requirements:
- Educational qualification: MBBS, MD in pharmacology, or pathology
- Preferred: 0-2 + years of experience as an investigator
- Skills:
- Good knowledge of Clinical research, specifically in Bioequivalence (BE) studies.
- Excellent understanding of regulatory requirements and market dynamics in these regions.
- Proven ability to generate and close business deals in the pharmaceutical/clinical research sector.
- Strong communication, negotiation, and presentation skills.
- Ability to travel internationally as needed.
Link to apply:
Keywords: Clinical Research, Investigational, Bioequivalence Studies, Job Postings, Regulatory Requirements, Business Deals
