Clinical Research Coordinator
About the Role
Roles & Responsibilities:
• Assist Principal Investigator (PI) in site feasibility assessments
• Support pre-trial documentation and regulatory readiness
• Collect and maintain updated CVs of site staff
• Ensure timely completion of financial disclosure forms, PI undertaking, and confidentiality agreements
• Coordinate with IRB/IEC for faster approvals and timely submission of safety reports and protocol amendments
• Assist PI & Co-Investigators in Informed Consent Process
• Prepare for Site Initiation Visits (SIV)
• Maintain Site Master File (SMF) and patient files
• Handle patient recruitment, screening, enrollment, and follow-ups
• Complete CRF and clinical data entry
• Coordinate patient follow-up visits (physical & telephonic)
• Report and follow-up on SAE (Serious Adverse Events)
• Manage drug accountability and inventory tracking
• Maintain study budget sheets and track IRB fees, site administration fees, lab costs, and patient reimbursements
Qualification:
• B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences
Experience:
• 1–4 years in clinical research / clinical trials
Skills:
• Knowledge of ICH-GCP Guidelines
• Experience with IRB/IEC Submissions
• SAE Reporting & Drug Safety
• CRF Completion & Clinical Data Management
• Patient Recruitment & Site Coordination
About The Company:
Max Healthcare is one of India’s leading hospital networks, offering an advanced research ecosystem for clinical trials. The company is focused on providing comprehensive healthcare and pioneering clinical research that adheres to global standards, promoting patient safety and the highest standards of care.
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