Clinical Research Physician

Role & Responsibilities
• Provide ongoing medical monitoring for assigned clinical trials
• Conduct real-time safety review of AEs and SAEs to ensure participant safety
• Evaluate safety signals, trends, laboratory and ECG abnormalities
• Contribute to protocol development, amendments and review of IBs, CSRs and SAPs
• Support preparation and review of safety narratives, DSURs and periodic safety reports
• Collaborate with pharmacovigilance teams for safety data management and regulatory responses
• Participate in Steering Committees and Data Safety Monitoring Boards (DSMBs)
• Provide medical expertise during site initiation, monitoring visits, audits and inspections
• Review inclusion/exclusion criteria for complex cases and manage protocol deviations with CAPA
• Ensure compliance with ICH-GCP, regulatory and ethical guidelines
• Support regulatory submissions and inspection readiness activities
• Deliver medical training to internal teams and site staff
• Work cross-functionally with clinical operations, data management, biostatistics and project teams

Qualifications 
• MD or equivalent medical degree (specialty training preferred)

Experience
• 3–7 years of clinical research experience in pharma, biotech or CRO
• Prior experience as Medical Monitor / Safety Physician preferred
• Strong understanding of ICH-GCP, FDA, EMA and CDSCO regulatory requirements
• In-depth knowledge of clinical trial methodology and drug development lifecycle

Skills
• Medical monitoring and safety signal evaluation
• Protocol development and regulatory documentation
• Pharmacovigilance and safety reporting
• Clinical trial compliance and audit readiness
• Cross-functional collaboration and stakeholder management
• Scientific writing and medical training delivery

About the Company
• Micro Crispr Pvt. Ltd. is a biotechnology-driven organization focused on innovative research and clinical development solutions, supporting advanced clinical programs through strong scientific, regulatory and ethical standards