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Cra Ii / Sr. Cra I (Oncology)

Syneos Health
Syneos Health
5+ 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: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology

 

CRA II / Sr. CRA I (Oncology)
Location: India (Client-Based Role)
Company: Syneos Health
Job ID: 25108464
Job Type: Full-Time
Industry: Clinical Research / Oncology / Pharmaceutical Research


About the Company

Syneos Health is a globally recognized full-service life sciences organization dedicated to accelerating customer success across clinical development, medical affairs, and commercialization. The company partners 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 scientific expertise, operational excellence, and patient-focused innovation to drive meaningful healthcare outcomes and clinical advancement.


Job Overview

Syneos Health is hiring experienced clinical research professionals for the position of CRA II / Sr. CRA I (Oncology). The selected candidate will be responsible for monitoring oncology clinical trials, ensuring regulatory compliance, managing investigator site activities, and supporting high-quality clinical study execution.

This role is ideal for candidates with strong oncology monitoring experience, in-depth knowledge of ICH-GCP guidelines, and expertise in site management within pharmaceutical, CRO, or clinical research environments.


Key Responsibilities

  • Perform site qualification, initiation, monitoring, management, and close-out visits
  • Ensure compliance with:
    • ICH-GCP Guidelines
    • Regulatory requirements
    • Study protocols
    • Company SOPs and processes
  • Evaluate site performance and provide recommendations for improvement
  • Escalate critical issues and support corrective action planning
  • Verify informed consent documentation and patient confidentiality procedures
  • Assess protocol deviations, safety concerns, and pharmacovigilance-related issues
  • Conduct source document review and verify accuracy of clinical trial data
  • Support query resolution and ensure timely data clarification activities
  • Monitor compliance with electronic data capture (EDC) systems and requirements
  • Review investigational product (IP) storage, dispensing, reconciliation, and accountability
  • Reconcile Investigator Site File (ISF) with Trial Master File (TMF)
  • Maintain essential clinical documentation and monitoring reports
  • Support patient recruitment, retention, and site engagement initiatives
  • Participate in investigator meetings, sponsor discussions, and clinical training programs
  • Ensure audit readiness and support inspection preparation activities
  • Collaborate with project teams, sponsors, and site personnel throughout the study lifecycle
  • Train or guide junior staff members when required

Required Qualifications

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

Experience Requirements

  • Minimum 5+ years of clinical monitoring experience
  • Strong oncology clinical trial experience is mandatory
  • Prior experience in site monitoring, site management, and sponsor coordination is highly preferred
  • Freshers are not eligible for this role