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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 – 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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