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Cra Ii/ Sr Cra I (Mumbai Location, Client Based) (Oncology)

3-5 years
Not Disclosed
10 Sept. 22, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

CRA II / Sr CRA I (Client-based, Oncology)

Location: Mumbai, India (Client-based)
Job ID: 25101933
Updated: September 17, 2025


Company Overview – Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success through clinical, medical affairs, and commercial insights.

Key Highlights:

  • Operates in 110 countries with 29,000 employees.

  • Partnered with 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products, 200+ studies, 73,000 sites, and 675,000+ trial patients in the past 5 years.

  • Promotes career development, technical training, peer recognition, and a Total Self culture.

Learn more: Syneos Health


Role Summary

CRA II / Sr CRA I is responsible for monitoring clinical research studies, ensuring regulatory compliance, protocol adherence, and data integrity. The role involves on-site and remote monitoring, site management, and risk-based monitoring in therapeutic areas like Oncology, Hematology, Cardiology, Neuropsychiatry, Rare Diseases, and Immunology.


Key Responsibilities

  • Site Monitoring & Management:

    • Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remote).

    • Assess site staff performance, escalate serious issues, and develop corrective action plans.

    • Verify informed consent and ensure subject/patient confidentiality.

  • Clinical Data Oversight:

    • Source document review, CRF data verification, and query resolution.

    • Ensure electronic data capture compliance and accurate reporting of investigational product (IP) administration.

    • Maintain Investigator Site File (ISF) and reconcile with Trial Master File (TMF).

  • Project Coordination:

    • Document activities via trip reports, follow-up letters, and communication logs.

    • Track observations, status, and action items in tracking systems.

    • Prepare for investigator meetings and sponsor interactions.

    • Support audit readiness and follow-up actions.

  • Real-World / Late Phase Studies:

    • Support site identification through close-out, including chart abstraction and data collection.

    • Collaborate with sponsor affiliates, medical science liaisons, and local staff.

    • Train junior staff and identify out-of-scope activities.

  • Compliance & Guidelines:

    • Maintain working knowledge of ICH/GCP Guidelines, regulatory requirements, and SOPs.

    • Complete project-specific training and adhere to company processes.


Qualifications & Skills

  • Education: Bachelor’s degree or RN in a related field (Pharma background preferred).

  • Experience: Minimum 3–5 years of clinical monitoring experience, preferably in Oncology or related therapeutic areas.

  • Skills:

    • Knowledge of GCP/ICH Guidelines and applicable regulatory requirements.

    • Strong computer literacy and adaptability to new technologies.

    • Excellent communication, presentation, and interpersonal skills.

    • Ability to travel up to 75% regularly.


Additional Information

  • Tasks and responsibilities are not exhaustive; additional duties may be assigned.

  • Equivalent experience may be considered in lieu of formal qualifications.

  • Nothing in this description constitutes an employment contract.

  • Syneos Health complies with ADA and applicable local regulations.


How to Apply

  • Apply via the Syneos Health website.

  • Not ready to apply? Join the Talent Network to stay connected for future opportunities.