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Clinical Research Coordinator

Max Healthcare
Max healthcare
1-2 years
Not Disclosed
New Delhi, India
10 Feb. 24, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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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