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Sr Cra I – Clinical Research Associate (Ophthalmology & Oncology)

Syneos Health
Syneos Health
5-6 years
preferred by company
Gurugram, India
1 May 11, 2026
Job Description
Job Type: Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Research & Development, Technical Skill, Triage of ICSRs

Sr CRA I – Clinical Research Associate (Ophthalmology & Oncology)

Company: Syneos Health
Job Title: Sr CRA I (Ophthalmology & Oncology Experience)
Location: Gurugram, India
Work Model: Hybrid
Job ID: 25107812
Department: Clinical Operations / Clinical Research


About the Role

Syneos Health is hiring a Sr CRA I for its Clinical Research and Clinical Operations team. This hybrid opportunity is ideal for professionals with strong experience in Clinical Monitoring, Oncology Trials, Ophthalmology Studies, Site Management, and ICH-GCP Compliance.

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

This opportunity is best suited for candidates with 5–6 years of Clinical Research and Site Monitoring experience, particularly in Ophthalmology and Oncology therapeutic areas.


Key Responsibilities

Clinical Site Monitoring & Site Management

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

Patient Safety & Regulatory Compliance

  • Verify informed consent procedures are appropriately documented
  • Protect subject/patient confidentiality and data privacy
  • Identify protocol deviations, pharmacovigilance concerns, and patient safety risks
  • Escalate serious compliance or operational issues to project teams
  • Support audit readiness and follow-up actions

Clinical Data Review & Query Management

  • Conduct:
    • Source Document Review (SDR)
    • Source Data Verification (SDV)
    • CRF review activities
  • Verify accuracy and completeness of clinical trial data
  • Resolve data queries remotely and during site visits
  • Support electronic data capture (EDC) compliance

Investigational Product & Trial Documentation

  • Review investigational product (IP) inventory and reconciliation
  • Ensure proper IP storage, dispensing, labeling, and accountability
  • Maintain and reconcile:
    • Investigator Site File (ISF)
    • Trial Master File (TMF)
  • Ensure compliance with document archival requirements

Project Coordination & Cross-Functional Collaboration

  • Manage site-level timelines and communication activities
  • Support patient recruitment and retention strategies
  • Collaborate with:
    • Clinical Operations teams
    • Sponsors
    • Medical Science Liaisons
    • Regulatory teams
  • Participate in:
    • Investigator Meetings
    • Sponsor meetings
    • Clinical training sessions
    • Bid defense meetings

Leadership & Mentorship

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

Real World Late Phase (RWLP) Support

  • Support study lifecycle activities from site identification through close-out
  • Participate in chart abstraction and data collection
  • Assist in country-level informed consent form development
  • Collaborate with RWLP Regulatory teams on local regulatory updates

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 and clinical research experience

Required Experience

  • 5 to 6 years of Clinical Research experience
  • Minimum 5 years of Clinical Monitoring experience

Mandatory Therapeutic Area Experience

  • Ophthalmology
  • Oncology

Preferred Experience Areas

  • Site management
  • Clinical trial monitoring
  • Patient safety and pharmacovigilance oversight
  • Real World Late Phase (RWLP) studies