Clinical Research PhysicianMicro Crispr Pvt. Ltd. • Ahmedabad, Gujarat, India
Clinical Research Physician
Micro Crispr Pvt. Ltd. • Ahmedabad, Gujarat, India
2 days ago
Job descriptionContribute to clinical protocol writing, amendments, and study-related documents (IB, CSR, SAP). KOL engagement Ensure protocol design is scientifically rigorous, ethical, and aligned with regulatory expectations. Participate in the development of informed consent forms and patient information sheets. Support the preparation and review of safety narratives, Development Safety Update Reports (DSURs), and periodic safety reports. Collaborate with pharmacovigilance teams to manage safety data and address regulatory safety queries. Serve as a core member for the coordination with Steering committee, DSMB etc. as applicable. Provide medical expertise to investigators, study teams, and CRO partners during site initiation, monitoring visits, and audits. Review inclusion / exclusion decisions for complex or borderline cases. Support resolution of protocol deviations and ensure appropriate corrective / preventive actions. Ensure studies comply with ICH-GCP, applicable regulatory requirements, and ethical guidelines. Provide medical input to regulatory submissions, responses to health authority queries, and inspection readiness activities. Partner with clinical operations, data management, biostatistics, and project management to ensure high-quality trial execution. Deliver medical training to internal teams and site staff as required. Education : MD (or equivalent medical degree); board certification or specialty training preferred (e.g., oncology, cardiology, internal medicine, or other relevant field). Experience : 3+ years of clinical research experience in pharma, biotech, or CRO (clinical development, medical affairs, or pharmacovigilance). Direct experience as a medical monitor or safety physician preferred. Knowledge : In-depth understanding of clinical trial methodology, ICH-GCP, regulatory guidelines (FDA, EMA, CDSCO, etc.). Familiarity with safety reporting requirements and drug development lifecycle.
Medical Oversight
- Provide ongoing medical monitoring of assigned clinical trials, including real-time safety review of adverse events (AEs) and serious adverse events (SAEs).
- Evaluate safety signals, trends, and laboratory / ECG abnormalities to ensure participant well-being.
- Assess investigator-reported causality and provide independent medical judgment when required.
2. Protocol Development and Study Design
3. Safety Management
4. Study Conduct and Medical Support
5. Regulatory and Ethical Compliance
6. Cross-Functional Collaboration
Qualifications & Requirements
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Clinical Research • Ahmedabad, Gujarat, India
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