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Clinical Research Associate (Cra I / Ii)

Icon Plc
ICON PLC
3+ years
preferred by company
Mumbai, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing

Clinical Research Associate (CRA I / II)

Location: Mumbai, India
Company: ICON plc
Job Type: Full-Time
Work Mode: Office With Flex (Hybrid)
Department: Clinical Research / Clinical Operations
Job Reference ID: JR135624
Industry: Clinical Research | CRO | Pharmaceutical | Biotechnology

Job Overview

ICON plc is hiring a Clinical Research Associate (CRA I / II) in Mumbai for its global clinical research operations team. This opportunity is ideal for experienced clinical research professionals with expertise in site monitoring, clinical trial management, ICH-GCP compliance, oncology trials, immunology studies, site relationship management, and patient safety oversight.

As a Clinical Research Associate, you will be responsible for end-to-end site monitoring activities, ensuring clinical trials are conducted in compliance with protocols, regulatory requirements, and global quality standards. You will work closely with investigators, study coordinators, sponsors, and internal cross-functional teams to support successful study delivery.

This role is ideal for professionals looking to grow in clinical operations, site monitoring, oncology clinical trials, immunology research, and global CRO careers.

Key Responsibilities

Clinical Trial Site Monitoring

  • Conduct clinical trial site visits, including:
    • Site qualification visits
    • Site initiation visits
    • Routine monitoring visits
    • Close-out visits

Ensure studies are executed according to protocol and regulatory expectations.

Protocol Compliance & Patient Safety

  • Monitor study sites to ensure:
    • Protocol adherence
    • Patient safety protection
    • Accurate trial conduct
    • Regulatory compliance
    • Ethical clinical research practices

Support inspection-ready trial execution.

Clinical Data Review & Query Resolution

  • Review clinical trial data for accuracy, consistency, and completeness.
  • Identify discrepancies and coordinate timely query resolution.
  • Ensure clean, reliable, high-quality study data.

Site Relationship Management

  • Build and maintain strong relationships with:
    • Principal Investigators
    • Site coordinators
    • Clinical site teams
    • Internal study stakeholders

Act as a trusted point of contact between study teams and clinical sites.

Clinical Documentation Support
Contribute to preparation and review of:

  • Clinical study documentation
  • Monitoring reports
  • Protocol-related documentation
  • Clinical study reports
  • Site management records
  • Regulatory documentation

Therapeutic Area Monitoring
Support clinical studies in:

  • Oncology (mandatory)
  • Immunology (mandatory)

Apply therapeutic expertise during monitoring and study oversight activities.

Cross-Functional Collaboration
Collaborate with:

  • Clinical Operations
  • Data Management
  • Medical Monitoring
  • Regulatory teams
  • Sponsors
  • Site personnel

Ensure smooth study execution across all phases.

Required Educational Qualification
Candidates must have:

  • Bachelor’s Degree in:
    • Life Sciences
    • Pharmacy
    • Biotechnology
    • Nursing
    • Healthcare
    • Biomedical Sciences
    • Related scientific discipline

Experience Required

  • Minimum 3+ years of Clinical Research Associate experience
  • Freshers are not eligible

Mandatory experience:

  • On-site clinical monitoring
  • Clinical trial site management
  • CRA responsibilities in CRO / pharmaceutical settings

Required therapeutic experience:

  • Oncology (mandatory)
  • Immunology (mandatory)