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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: M.Pharm/B.Pharm or M.Sc. Skills: Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development

    Job Title: Clinical Research Associate (CRA)

    Location: Mumbai, Maharashtra, India
    Job Type: Full-Time
    Experience Required: 1–5 Years (Freshers may be considered only if they have relevant clinical research training; experienced candidates preferred)
    Industry: Clinical Research / Pharmaceuticals / Medical Affairs / Healthcare / Drug Development
    Department: Medical Affairs & Clinical Research

    About the Role
    We are seeking a proactive and detail-oriented Clinical Research Associate (CRA) to support clinical trial operations, site management, regulatory compliance, and study execution within a fast-paced pharmaceutical research environment. This role is ideal for professionals with hands-on experience in clinical trial monitoring, investigator site management, regulatory submissions, pharmacovigilance coordination, and clinical data oversight.

    The ideal candidate will play a critical role in ensuring clinical studies are conducted in compliance with protocol requirements, Good Clinical Practice (GCP), regulatory guidelines, and organizational quality standards while supporting timely study delivery and participant safety.

    This opportunity is well suited for early to mid-career clinical research professionals looking to grow in pharmaceutical clinical operations.

    Key Responsibilities

    Clinical Trial Site Management & Monitoring

    • Conduct site feasibility assessments and identify suitable investigators and research sites for clinical studies.
    • Support investigator selection, site qualification, confidentiality agreement execution, and study contract coordination.
    • Ensure timely completion of site initiation visits (SIV), routine monitoring visits, interim monitoring, and site close-out activities.
    • Generate accurate monitoring reports and maintain study documentation in accordance with compliance requirements.

    Regulatory Submissions & Ethics Committee Coordination

    • Prepare and coordinate submission of study documentation for Ethics Committee (EC) approvals across multiple study centers.
    • Support regulatory documentation readiness and compliance tracking throughout the clinical study lifecycle.
    • Ensure study activities align with applicable regulatory requirements, internal SOPs, and GCP standards.

    Clinical Trial Operations & Participant Management

    • Oversee investigational product (IP) dispensing, inventory management, reconciliation, and accountability processes.
    • Support timely participant recruitment and enrollment activities in collaboration with site teams.
    • Ensure efficient study conduct, protocol adherence, and high-quality operational execution at assigned sites.

    Data Quality & Clinical Documentation Oversight

    • Perform source data verification (SDV) and support timely clinical data entry, review, and query resolution.
    • Ensure study documentation accuracy, completeness, and alignment with protocol requirements.
    • Coordinate with internal data management teams or CRO partners to support database activities and study deliverables.

    Safety Reporting & Pharmacovigilance Coordination

    • Ensure timely reporting of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) according to applicable regulations and pharmacovigilance policies.
    • Coordinate communication of safety information with investigators, research sites, and internal safety teams.
    • Support participant safety monitoring and pharmacovigilance compliance throughout study execution.

    Risk Management & Cross-Functional Collaboration

    • Identify operational risks, site performance concerns, and protocol deviations.
    • Support root cause analysis and implementation of Corrective and Preventive Actions (CAPA) where required.
    • Collaborate with clinical operations, CRO partners, biostatistics, data management, pharmacovigilance, and medical affairs teams.

    Investigator Training & Study Support

    • Train investigators and site personnel on study protocols, procedures, compliance expectations, and GCP principles.
    • Support consistent communication with investigators and research teams to ensure high-quality study execution.

    Required Qualifications

    • Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biology, Chemistry, Nursing, Public Health, Biomedical Sciences, or related healthcare disciplines.
    • Postgraduate Diploma in Clinical Research is an added advantage.
    • 1–5 years of relevant clinical research experience in pharmaceutical companies, CROs, hospitals, or clinical trial environments.
    • Strong understanding of ICH-GCP guidelines, clinical trial monitoring, ethics submissions, pharmacovigilance processes, and study documentation.
    • Experience in clinical site monitoring, source data verification, investigator coordination, and safety reporting preferred.
    • Strong analytical, documentation, communication, and stakeholder management skills.
    • Ability to manage multiple clinical sites and timelines effectively.

    Preferred Skills

    • Clinical trial monitoring
    • Site feasibility assessment
    • Investigator site management
    • Ethics Committee submissions
    • Source Data Verification (SDV)
    • SAE / SUSAR reporting
    • Investigational product management
    • GCP compliance
    • CAPA management
    • Clinical operations coordination
    • CRO collaboration
    • Clinical documentation oversight

    Why Join This Opportunity?

    • Work on impactful pharmaceutical clinical research programs.
    • Gain exposure to end-to-end clinical trial execution and regulatory operations.
    • Collaborate with experienced clinical research, safety, and medical affairs teams.
    • Build strong expertise in clinical monitoring and drug development operations.
    • Strong career progression opportunities in clinical operations and research management

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