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

Syneos Health
Syneos Health
5+ 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: ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding

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

Company: Syneos Health
Job Title: CRA II / Sr. CRA I (Oncology)
Location: India (Client-Based Role)
Job ID: 25108464
Department: Clinical Operations / Clinical Research


About the Role

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

The selected candidate will manage end-to-end clinical site monitoring activities including site qualification, initiation, interim monitoring, close-out visits, source data verification, investigational product accountability, and regulatory compliance across oncology studies.

This role is best suited for candidates with 5+ years of Clinical Monitoring experience and mandatory Oncology therapeutic area expertise.


Key Responsibilities

Clinical Site Monitoring & Site Management

  • Perform:
    • Site Qualification Visits (SQV)
    • Site Initiation Visits (SIV)
    • 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 investigator site performance and recommend corrective actions

Patient Safety & Regulatory Compliance

  • Verify informed consent processes are properly completed and documented
  • Protect patient confidentiality and clinical data integrity
  • Identify protocol deviations, pharmacovigilance issues, and patient safety risks
  • Escalate critical issues to project teams and support corrective action planning
  • Maintain audit readiness and regulatory compliance standards

Clinical Data Review & Query Resolution

  • Conduct:
    • Source Document Review (SDR)
    • Source Data Verification (SDV)
    • CRF review activities
  • Ensure clinical data accuracy and completeness
  • Perform query management and support timely resolution
  • Verify compliance with electronic data capture (EDC) requirements

Investigational Product & Documentation Management

  • Review investigational product (IP) inventory and reconciliation
  • Ensure appropriate IP storage, dispensing, and accountability
  • Review and reconcile:
    • Investigator Site File (ISF)
    • Trial Master File (TMF)
  • Ensure proper archiving of essential study documentation

Project Coordination & Stakeholder Collaboration

  • Support subject recruitment and retention strategies
  • Collaborate with:
    • Sponsors
    • Medical Science Liaisons
    • Clinical Operations teams
    • Local country teams
  • Participate in:
    • Investigator Meetings
    • Sponsor meetings
    • Clinical training sessions
    • Global project meetings
  • Manage site-level timelines, communication, and deliverables

Real World Late Phase (RWLP) Support

  • Support study lifecycle activities from site identification through close-out
  • Participate in chart abstraction and clinical data collection
  • Identify and communicate out-of-scope activities to Lead CRA or Project Managers
  • Recommend potential study sites based on local healthcare and treatment knowledge

Educational Qualification

Candidates should possess:

  • Bachelor’s Degree in a related 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 5+ years of Clinical Monitoring experience
  • Strong Oncology Clinical Trial experience

Preferred Experience Areas

  • Site management
  • Clinical operations
  • Oncology trial monitoring
  • Pharmacovigilance oversight
  • Real World Late Phase (RWLP) studies