Clinical Research Physician

2 weeks ago

Ahmedabad Gujarat India, Gujarat Micro Crispr Pvt. Ltd. Full time

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

  • Contribute 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.

3. Safety Management

  • 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.

4. Study Conduct and Medical Support

  • 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.

5. Regulatory and Ethical Compliance

  • 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.

6. Cross-Functional Collaboration

  • 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.

Qualifications & Requirements

  • 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.

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