Clinical Research Job for Medical Professionals at Micro Crispr | Apply
If you are looking for a rewarding Clinical Research Job, Micro Crispr Pvt. Ltd. is offering an excellent opportunity for medical professionals. This MD Job combines medical oversight, safety management, and regulatory compliance within a growing biotechnology company. Professionals seeking impactful medical jobs in clinical development will find this role both challenging and career-defining.
Job Title: Clinical Research Physician
About the Company:
Micro Crispr Pvt. Ltd. is a growing biotechnology company dedicated to advancing innovative clinical development programs. The organization provides exciting biotechnology company jobs for professionals passionate about medical research, safety monitoring, and regulatory excellence. This Clinical Research Job offers exposure to high-quality trial execution and cross-functional collaboration.
Job Description:
This Clinical Research Job involves providing ongoing medical monitoring of assigned clinical trials, including real-time safety review of adverse events (AEs) and serious adverse events (SAEs). The role includes evaluating safety signals, contributing to clinical protocol writing and study-related documents (IB, CSR, SAP), supporting safety management activities such as DSURs and periodic safety reports, ensuring compliance with ICH-GCP and regulatory guidelines, and partnering with cross-functional teams to ensure high-quality trial execution. This MD Job requires strong medical oversight, regulatory understanding, and collaboration within a biotechnology company environment.
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.
Key Responsibilities:
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.
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.
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 the Steering committee, DSMB, etc., as applicable.
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.
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.
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.
