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    Clinical Research Associate (Cra)

    Sun Pharma
    Sun Pharma
    1-5 years
    preferred by company
    Mumbai, India
    1 May 13, 2026
    Job Description
    Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ, Communication Skills, Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat

    Job Title: Clinical Research Associate (CRA)

    Company: Sun Pharma
    Location: Mumbai, India
    Business Unit: Medical Affairs & Clinical Research
    Employment Type: Full-Time
    Industry: Clinical Research / Pharmaceuticals / Medical Affairs / Drug Development

    Job Overview

    We are hiring a Clinical Research Associate (CRA) to manage clinical trial execution, site monitoring, investigator coordination, regulatory documentation, patient recruitment oversight, and study compliance activities.

    This role is ideal for professionals with expertise in clinical trial monitoring, GCP compliance, site management, clinical operations, pharmacovigilance coordination, and CRO/pharma clinical research execution.

    The ideal candidate will support end-to-end clinical study activities from site feasibility through closeout while ensuring protocol adherence, regulatory compliance, and high-quality trial execution.

    Key Responsibilities

    Site Feasibility & Site Selection

    • Conduct site feasibility assessments.
    • Identify and evaluate potential investigators.
    • Assess site capability for study execution.
    • Support investigator/site selection decisions.

    Responsibilities include:

    • Site qualification
    • Investigator identification
    • Site readiness evaluation

    Contract & Budget Coordination

    • Negotiate study budgets with investigators/sites.
    • Support finalization of:
      • Clinical study contracts
      • Confidential Disclosure Agreements (CDA)
      • Study-related documentation

    Coordinate execution of contractual processes.

    Ethics Committee / Regulatory Documentation

    • Prepare study documentation for Ethics Committee (EC) submissions.
    • Coordinate regulatory package submissions across study centers.
    • Support approval tracking and documentation readiness.

    Clinical Trial Monitoring

    Manage core monitoring activities including:

    • Site initiation visits (SIV)
    • Routine monitoring visits
    • Site close-out visits (COV)
    • Monitoring documentation
    • Monitoring reports

    Ensure trial conduct aligns with protocol and GCP standards.

    Investigational Product (IP) Management

    Oversee:

    • IP dispensing documentation
    • Drug accountability
    • Inventory tracking
    • Reconciliation activities

    Ensure investigational product compliance and documentation accuracy.

    Site Training & Study Enablement

    Train investigators and site teams on:

    • Study protocol
    • Study procedures
    • Good Clinical Practice (GCP)
    • Safety reporting expectations
    • Trial documentation standards

    Support study readiness.

    Patient Recruitment & Enrollment Oversight

    • Monitor recruitment progress.
    • Support timely participant enrollment.
    • Identify enrollment risks or delays.
    • Work with sites to improve recruitment performance.

    Data Quality & Source Verification

    Support:

    • Source Data Verification (SDV)
    • Data entry oversight
    • Query management
    • Data accuracy reviews

    Ensure clean, reliable clinical trial data.

    Safety & Pharmacovigilance Coordination

    Support safety reporting processes for:

    • SAE reporting
    • SUSAR reporting
    • Safety communication to investigators/sites

    Ensure alignment with:

    • Regulatory requirements
    • Internal pharmacovigilance policies

    Risk Management & CAPA

    • Identify site-level risks.
    • Perform issue analysis.
    • Develop and track:
      • CAPA plans
      • Risk mitigation actions
      • Performance improvement measures

    Support study quality management.

    Cross-Functional Coordination

    Collaborate with:

    • Clinical operations
    • Data management
    • Biostatistics
    • Pharmacovigilance
    • CRO partners
    • Investigators
    • Internal study teams

    Support:

    • Statistical analysis coordination
    • Database lock preparation
    • Trial milestone execution

    Required Qualifications

    Education

    Bachelor’s or Master’s degree in:

    • Biology
    • Chemistry
    • Nursing
    • Pharmacy
    • Public Health
    • Life Sciences
    • Related healthcare fields

    OR

    • Postgraduate Diploma in Clinical Research

    Experience Required

    1–5 years of relevant clinical research experience

    Preferred backgrounds:

    • Pharmaceutical companies
    • CROs
    • Clinical operations
    • Site monitoring roles

     

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