Clinical Research Coordinator
Job Code: MHC/26049
Department: Clinical Research
Location: Dwarka – Max Super Speciality Hospital
Employment Type: Full-Time
Number of Openings: 1
Application Deadline: 02 March 2026
Experience Required: 1–2 Years
About the Organization
Max Super Speciality Hospital Dwarka is a leading tertiary care healthcare institution known for advanced clinical services and research excellence. The Clinical Research Department supports national and international clinical trials across multiple therapeutic areas, ensuring adherence to regulatory, ethical, and Good Clinical Practice (GCP) standards.
Role Overview
The Clinical Research Coordinator (CRC) will support the Principal Investigator (PI) and study team in the end-to-end management of clinical trials. This role involves regulatory submissions, site management, patient coordination, safety reporting, documentation compliance, and financial tracking in accordance with ICH-GCP guidelines, institutional policies, and regulatory requirements.
This position is ideal for professionals seeking career growth in clinical operations, site management, and regulatory compliance within hospital-based research settings.
Educational Qualification
Bachelor of Science (BSc)
Master of Science (MSc) preferred
Experience Required
Minimum 1–2 years of experience in clinical research coordination
Experience in hospital-based or investigator-initiated trials preferred
Exposure to IRB submissions, SAE reporting, and clinical trial documentation is desirable
Knowledge of ICH-GCP and regulatory guidelines is an advantage
Key Responsibilities
1. Site Feasibility & Study Start-Up
Assist the Principal Investigator in completing site feasibility assessments for proposed clinical trials
Collect updated CVs and essential documents from site team members
Ensure timely completion of pre-trial documentation including:
Financial Disclosure Forms
PI Undertaking
Confidentiality and Non-Disclosure Agreements
Data Confidentiality Forms
Support preparation for Site Initiation Visits (SIV)
2. IRB Submissions & Regulatory Compliance
Prepare and submit regulatory documents to the Institutional Review Board (IRB)
Follow up for expedited IRB approvals
Ensure timely submission of:
Safety reports
Protocol amendments
Six-monthly and annual reports
CTA/MOU notifications
Serious Adverse Event (SAE) reports
3. Patient Recruitment & Study Coordination
Maintain patient screening and enrollment logs
Conduct pre-screening, screening, recruitment, and enrollment activities
Assist PI and Co-Investigators in the informed consent process
Coordinate and schedule subject visits (physical and telephonic follow-ups)
Organize investigator, sponsor, and patient meetings
4. Documentation & Data Management
Maintain Site Master File and patient files
Create and update source documents and templates
Complete Case Report Forms (CRFs) and perform accurate data entry
Ensure data accuracy, integrity, and protocol compliance
5. Drug Accountability & Safety Oversight
Maintain drug accountability logs
Coordinate investigational product storage and documentation
Support SAE documentation and regulatory communication
6. Financial Responsibilities
Maintain study budget sheets
Process IRB fee invoices and site administration charges
Track laboratory costs and subject-related expenses
Coordinate reimbursements for subject treatment, investigations, travel, and related costs
Core Competencies
Strong understanding of ICH-GCP and clinical trial lifecycle
Excellent documentation and regulatory compliance skills
Attention to detail and data accuracy
Effective communication and coordination skills
Ability to manage multiple studies simultaneously
Patient-centric approach with ethical conduct
Why Apply?
This role provides exposure to full-spectrum clinical trial operations including feasibility, regulatory submissions, patient recruitment, safety reporting, and financial management. It offers hands-on experience in hospital-based research aligned with global compliance standards.
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