Clinical Research Coordinator
Job Code: MHC/26049
Department: Clinical Research
Location: Dwarka, New Delhi, India
Organization: Max Super Speciality Hospital Dwarka
Employment Type: Full-Time
Employee Category: Support
Number of Openings: 1
Application Deadline: 02 March 2026
Experience Required: 1–2 Years
About the Clinical Research Department
The Clinical Research Unit at Max Super Speciality Hospital, Dwarka conducts investigator-initiated and sponsor-driven clinical trials across therapeutic areas. The department operates in compliance with ICH-GCP guidelines, institutional SOPs, and regulatory authority requirements to ensure ethical and scientifically sound research practices.
Role Overview
The Clinical Research Coordinator (CRC) will support the Principal Investigator (PI) and Co-Investigators in managing clinical trials from feasibility assessment to study close-out. The role requires expertise in regulatory documentation, IRB submissions, patient recruitment, safety reporting, data management, and financial coordination.
This opportunity is ideal for professionals seeking growth in hospital-based clinical research, regulatory compliance, and trial operations.
Educational Qualification
Bachelor of Science (B.Sc.)
Master of Science (M.Sc.) preferred
Experience Required
1–2 years of experience in clinical research coordination
Experience with IRB submissions and regulatory documentation
Exposure to SAE reporting and safety compliance preferred
Working knowledge of ICH-GCP guidelines and clinical trial lifecycle
Key Responsibilities
Site Feasibility & Study Start-Up
Assist the PI in completing site feasibility assessments for proposed trials
Collect and maintain updated CVs and regulatory documents of study team members
Ensure timely completion of pre-trial documentation including:
Financial Disclosure Forms
PI Undertakings
Confidentiality and Non-Disclosure Agreements
Data Confidentiality Forms
Prepare documentation for Site Initiation Visits (SIV)
IRB Submissions & Regulatory Compliance
Prepare and submit applications to the Institutional Review Board (IRB)
Actively follow up to facilitate timely approvals
Ensure submission of protocol amendments, safety reports, six-monthly/annual reports, CTA/MOU notifications, and SAE reports
Maintain regulatory correspondence records
Patient Recruitment & Study Coordination
Maintain screening, enrollment, and subject tracking logs
Conduct pre-screening, screening, recruitment, and enrollment activities
Assist PI and Co-I in administering the informed consent process
Coordinate subject visits, follow-ups, and trial-related appointments
Organize investigator, sponsor, and patient meetings
Documentation & Data Management
Maintain Site Master File and patient study files
Create and manage source documents and templates
Complete Case Report Forms (CRFs) and perform accurate data entry
Ensure data integrity and protocol compliance
Drug Accountability & Safety Reporting
Maintain investigational product accountability logs
Support SAE documentation and regulatory reporting
Ensure compliance with safety monitoring requirements
Financial & Administrative Responsibilities
Maintain study budget sheets and expense tracking
Process IRB fee invoices and site administration charges
Track laboratory costs and subject-related reimbursements
Coordinate payments for treatment, investigations, travel, and related study expenses
Core Competencies
Strong knowledge of clinical trial processes and regulatory frameworks
Excellent documentation and organizational skills
Attention to detail and data accuracy
Effective communication with investigators, sponsors, and regulatory bodies
Ability to manage multiple ongoing studies simultaneously
Why Apply?
This role offers hands-on exposure to full-spectrum clinical trial management within a reputed tertiary care hospital. The position supports professional development in regulatory compliance, trial coordination, and patient-centric research operations.
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Find more clinical research and healthcare career opportunities at ThePharmaDaily.com.
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