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Sr. Cra Ii – Clinical Research & Site Monitoring (Oncology)

Syneos Health
Syneos Health
7+ years
preferred by company
PAN-India, India
1 May 11, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

Sr. CRA II – Clinical Research & Site Monitoring (Oncology)

Company: Syneos Health
Job Title: Sr. CRA II (Site Reviewing / Report Reviewing)
Location: India (Client-Based Role)
Job ID: 25108469
Department: Clinical Operations / Clinical Research


About the Role

Syneos Health is hiring a Sr. CRA II for its Clinical Operations and Oncology Research team. This opportunity is ideal for experienced professionals with expertise in Clinical Site Monitoring, Oncology Clinical Trials, Site Activation, Clinical Report Review, and ICH-GCP Compliance.

The selected candidate will manage site selection, site initiation, clinical monitoring, report review, regulatory compliance, and operational oversight activities across oncology clinical studies while collaborating with sponsors, project teams, and clinical stakeholders.

This role is best suited for candidates with 7+ years of onsite clinical monitoring experience and strong Oncology therapeutic expertise.


Key Responsibilities

Clinical Site Monitoring & Site Management

  • Perform:
    • Site Qualification Visits (SQV)
    • Site Initiation Visits (SIV)
    • Site Activation activities
    • Interim Monitoring Visits
    • Site Management activities
    • Site Close-Out Visits
  • Conduct on-site and remote monitoring activities
  • Ensure compliance with:
    • ICH-GCP Guidelines
    • Good Pharmacoepidemiology Practices (GPP)
    • Study protocols
    • Regulatory requirements
  • Evaluate site performance and recommend corrective actions when required

Site Start-Up & Activation Activities

  • Support country and site selection activities
  • Review draft site lists and assess feasibility requirements
  • Coordinate:
    • Site activation checklist activities
    • Informed Consent Document (ICD) finalization
    • Site initiation processes
  • Ensure timely completion of:
    • Site readiness activities
    • Required training
    • Documentation collection
    • System entries for activation
  • Manage issues impacting timelines proactively

Clinical Data Review & Query Resolution

  • Conduct:
    • Source Document Review (SDR)
    • Source Data Verification (SDV)
    • CRF review activities
  • Verify clinical trial data accuracy and completeness
  • Manage and resolve data queries remotely and on-site
  • Ensure compliance with electronic data capture (EDC) systems

Patient Safety & Regulatory Compliance

  • Verify informed consent procedures are appropriately completed and documented
  • Protect patient confidentiality and clinical data integrity
  • Identify:
    • Protocol deviations
    • Pharmacovigilance concerns
    • Patient safety risks
  • Escalate critical issues to project teams and support action planning
  • Maintain audit readiness and regulatory compliance standards

Investigational Product & Documentation Management

  • Review investigational product (IP) inventory and reconciliation
  • Ensure appropriate IP storage, dispensing, labeling, and accountability
  • Maintain and reconcile:
    • Investigator Site File (ISF)
    • Trial Master File (TMF)
  • Ensure proper archival of study documentation according to regulations

Stakeholder Collaboration & Project Coordination

  • Act as primary point of contact for study sites
  • Collaborate with:
    • Sponsors
    • Medical Science Liaisons
    • Clinical Operations teams
    • Regulatory teams
    • Local country staff
  • Participate in:
    • Investigator Meetings
    • Sponsor meetings
    • Clinical training sessions
    • Bid defense meetings
  • Support Requests for Proposals (RFPs), budgeting, and site management strategy development

Leadership & Mentorship

  • Provide supervision, mentoring, and training to junior CRAs
  • Conduct training and sign-off visits for junior staff
  • Support operational leadership activities under supervision
  • Identify operational efficiencies and process improvements

Real World Late Phase (RWLP) Support

  • Support studies throughout the lifecycle from site identification to close-out
  • Participate in:
    • Chart abstraction activities
    • Clinical data collection
    • Country-level informed consent form development
  • Collaborate with RWLP Regulatory teams for updated regulatory information

Educational Qualification

Candidates should possess:

  • Bachelor’s Degree in a healthcare or life sciences field
    OR
  • Registered Nurse (RN) qualification
    OR
  • Equivalent combination of education, training, and clinical research experience

Required Experience

Mandatory Experience

  • Minimum 7+ years of onsite Clinical Monitoring experience
  • Strong Oncology Clinical Trial experience

Preferred Experience Areas

  • Site activation and startup
  • Clinical report review
  • Site management and monitoring
  • Pharmacovigilance oversight
  • Real World Late Phase (RWLP) studies