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Sr. Cra Ii (Site Reviewing / Report Reviewing)

Syneos Health
Syneos Health
7+ years
Not Disclosed
PAN-India, India
1 May 8, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L.

Sr. CRA II (Site Reviewing / Report Reviewing)
Location: India (Client-Based Role)
Company: Syneos Health
Job ID: 25108469
Job Type: Full-Time
Industry: Clinical Research / Oncology / Clinical Operations


About the Company

Syneos Health is a globally recognized and fully integrated life sciences organization focused on accelerating customer success across clinical development, medical affairs, and commercialization. The company collaborates with pharmaceutical, biotechnology, and healthcare innovators to support the development and delivery of advanced therapies worldwide.

With more than 25,000 professionals globally, Syneos Health combines deep scientific expertise, operational excellence, and patient-focused innovation to drive meaningful advancements in healthcare and clinical research.


Job Overview

Syneos Health is hiring experienced clinical research professionals for the role of Sr. CRA II (Site Reviewing / Report Reviewing). The selected candidate will manage oncology clinical trial monitoring activities, site oversight, regulatory compliance, and site relationship management while ensuring high-quality execution of clinical studies.

This role is ideal for candidates with strong oncology monitoring expertise, extensive onsite clinical research experience, and advanced knowledge of ICH-GCP guidelines and site management processes.


Key Responsibilities

  • Conduct:
    • Site selection
    • Site qualification
    • Site initiation
    • Site activation
    • Interim monitoring
    • Site management
    • Close-out visits
  • Serve as the primary point of contact for assigned clinical trial sites
  • Support country and site selection activities, feasibility assessments, and protocol implementation
  • Coordinate site activation checklist activities, SIVs, and informed consent form (ICF/ICD) finalization
  • Ensure timely completion of post-site initiation and site readiness activities
  • Build and maintain strong relationships with investigators, sponsors, and site personnel
  • Ensure compliance with:
    • ICH-GCP guidelines
    • Regulatory requirements
    • Clinical Monitoring Plans
    • SOPs and protocol requirements
  • Conduct Source Document Review (SDR) and verify clinical data accuracy in CRFs
  • Manage query resolution and support site data quality improvements
  • Review Investigator Site Files (ISF) and reconcile with Trial Master Files (TMF)
  • Monitor investigational product (IP) handling, storage, reconciliation, and accountability
  • Support patient recruitment, retention, and site engagement initiatives
  • Participate in investigator meetings, sponsor meetings, and global clinical operations discussions
  • Provide guidance on audit readiness and inspection preparation activities
  • Mentor and train junior CRA professionals when required
  • Support business development activities, bid defense meetings, and RFP contributions
  • Identify operational efficiencies and process improvement opportunities
  • Contribute to study documentation, informed consent forms, and site management strategies

Required Qualifications

  • Bachelor’s degree in:
    • Life Sciences
    • Pharmacy
    • Biotechnology
    • Nursing
    • Healthcare-related disciplines
  • Registered Nurse (RN) qualification or equivalent experience may also be considered
  • Strong understanding of:
    • Clinical trial monitoring
    • Oncology studies
    • ICH-GCP guidelines
    • Regulatory compliance
    • Clinical documentation standards