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    Senior Cra Ii (Site Review / Report Review) – Oncology

    Syneos Health
    Syneos Health
    7+ years
    preferred by company
    PAN-India, India
    1 May 13, 2026
    Job Description
    Job Type: Hybrid Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

    Job Title: Senior CRA II (Site Review / Report Review) – Oncology

    Location: India (Client-Based / Field / Remote Monitoring Hybrid)
    Job Type: Full-Time
    Experience Required: 7+ Years (Freshers are not eligible)
    Industry: Clinical Research / CRO / Oncology Clinical Trials / Pharmaceuticals / Biotechnology / Life Sciences
    Department: Clinical Operations / Clinical Monitoring / Site Management

    About the Role
    We are seeking a highly experienced and strategic Senior CRA II (Site Review / Report Review) – Oncology to lead advanced clinical monitoring, site relationship management, study startup execution, report review oversight, and oncology trial delivery within global clinical research programs. This senior clinical operations role is ideal for professionals with expertise in oncology monitoring, site activation, clinical compliance, source data verification, audit readiness, and investigator site leadership.

    The ideal candidate will oversee site performance, clinical monitoring execution, patient safety oversight, study startup coordination, and operational excellence while serving as a trusted partner to sponsors, investigators, and internal project teams.

    This opportunity is highly suited for senior CRAs seeking advanced clinical leadership roles in oncology clinical research.

    Key Responsibilities

    Clinical Monitoring & Site Oversight

    • Lead comprehensive clinical monitoring activities across assigned oncology studies, including:
      • Site selection and qualification
      • Site initiation visits (SIVs)
      • Site activation readiness
      • Interim monitoring visits
      • Site management oversight
      • Remote monitoring activities
      • Site close-out visits
    • Evaluate site performance, compliance risks, operational quality, and study execution standards.
    • Develop site-specific action plans and escalate critical operational issues proactively.

    Oncology Clinical Trial Leadership

    • Apply strong expertise in Oncology clinical research to support complex therapeutic study execution.
    • Maintain deep understanding of assigned protocols, oncology treatment pathways, eligibility requirements, and clinical operational needs.
    • Support advanced site management strategies for oncology-focused programs.

    Study Startup & Site Activation Management

    • Coordinate site startup and activation activities including:
      • Site activation checklist completion
      • Informed Consent Document (ICD) finalization
      • Site readiness confirmation
      • Post-SIV follow-up
      • Documentation readiness for First Subject First Visit (FSFV)
    • Proactively identify startup risks and resolve issues impacting activation timelines.
    • Support country and regional site selection strategy, feasibility reviews, and site outreach initiatives.

    Site Relationship Management & Stakeholder Collaboration

    • Serve as the primary point of contact for assigned investigative sites.
    • Build strong relationships with investigators, site coordinators, healthcare professionals, sponsor stakeholders, and internal teams.
    • Collaborate with Central Monitoring Associates, Medical Science Liaisons (MSLs), sponsor affiliates, regulatory teams, and country stakeholders.
    • Maintain high-quality operational site engagement throughout the study lifecycle.

    Regulatory Compliance & Patient Safety Oversight

    • Ensure compliance with:
      • ICH-GCP guidelines
      • Good Pharmacoepidemiology Practices (GPP)
      • Local regulatory requirements
      • Sponsor SOPs
      • Clinical Monitoring Plans / Site Management Plans
    • Verify informed consent compliance and patient confidentiality protections.
    • Assess protocol deviations, pharmacovigilance concerns, clinical risks, and patient safety issues proactively.
    • Support audit readiness and regulatory inspection preparedness.

    Source Data Verification & Clinical Data Quality

    • Conduct Source Document Review (SDR) and Source Data Verification (SDV) to ensure data integrity and accuracy.
    • Review site medical records and confirm accurate Case Report Form (CRF) data entry.
    • Manage data query resolution and drive issue closure within agreed timelines.
    • Ensure compliance with electronic data capture systems and clinical documentation standards.

    Investigational Product (IP) Oversight

    • Review investigational product accountability, reconciliation, storage, dispensing, labeling, and return processes.
    • Ensure protocol-compliant handling of IP, including blinded/randomized study controls where applicable.
    • Verify compliance with local and sponsor IP governance requirements.

    TMF / ISF Documentation & Report Review

    • Review Investigator Site Files (ISF) for completeness, quality, timeliness, and regulatory compliance.
    • Reconcile site documentation with Trial Master File (TMF) expectations.
    • Maintain accurate monitoring documentation including:
      • Trip reports
      • Follow-up letters
      • Communication logs
      • Action trackers
      • Study documentation records
    • Support monitoring report review and documentation quality governance.

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