Clinical Research Coordinator
About the Role
Roles & Responsibilities
• Assist Principal Investigator (PI) in site feasibility and study start-up activities
• Prepare and maintain regulatory documents (CVs, Financial Disclosure, PI Undertaking, Confidentiality Agreements)
• Coordinate IRB/IEC submissions, safety reports, amendments, and progress reports
• Support informed consent process and prepare for Site Initiation Visits (SIV)
• Maintain Site Master File (SMF), patient files, screening & enrollment logs
• Manage patient pre-screening, recruitment, follow-ups, and visit coordination
• Ensure accurate CRF completion and clinical data entry
• Perform SAE reporting and follow-up activities
• Maintain drug accountability and inventory records
• Track study budgets, IRB fees, invoices, lab costs, and patient reimbursements
Qualification
• Any Graduate (Life Sciences / Pharmacy preferred)
Experience
• 1–4 years of experience in clinical research or clinical trial coordination
Skills
• Strong knowledge of ICH-GCP guidelines
• Experience in IRB/IEC submissions and regulatory documentation
• SAE reporting and drug safety awareness
• CRF completion and clinical data management
• Patient recruitment and site coordination skills
• Good communication, documentation, and organizational ability
About the Organization
Max Healthcare is one of India’s leading hospital networks, known for excellence in patient care and advanced medical research. The organization offers strong exposure to investigator-initiated and sponsored clinical studies within a reputed hospital research environment.
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