CRA II / Sr CRA I (Oncology) – Syneos Health
Location: Mumbai, India (Client-based)
Job ID: 25101933
Updated: September 17, 2025
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating clinical development and improving patient outcomes.
Employees: 29,000 across 110 countries
Experience: Worked with 94% of Novel FDA-approved drugs, 95% of EMA-authorized products, 200+ studies, 73,000 sites, and 675,000+ trial patients.
Culture: Total Self culture fostering diversity, authenticity, career growth, and inclusion.
Job Overview
The CRA II / Sr CRA I oversees clinical research studies with a focus on oncology. Responsibilities include site qualification, monitoring, and management (on-site and remote), ensuring compliance with ICH-GCP, regulatory requirements, and protocol guidelines. The role may also involve supporting Real World/late phase studies.
Key Responsibilities
Clinical Monitoring & Site Management:
Conduct site qualification, initiation, interim monitoring, site management, and close-out visits.
Verify informed consent and ensure patient confidentiality.
Conduct source document reviews, verify CRF data, and manage query resolution.
Oversee investigational product (IP) handling, including inventory, dispensing, administration, and compliance with protocol requirements.
Review and maintain Investigator Site Files (ISF) and reconcile with Trial Master File (TMF).
Project Coordination & Compliance:
Document activities through trip reports, letters, logs, and project tracking systems.
Support subject/patient recruitment, retention, and awareness strategies.
Understand project scope, timelines, and budgets; manage site-level communication.
Ensure audit readiness and support preparation for inspections.
Collaboration & Training:
Serve as primary liaison with study site personnel, sponsors, and Central Monitoring Associates.
Participate in investigator meetings, sponsor meetings, and project staff meetings.
Train junior staff as needed and identify out-of-scope activities.
Support Real World/late phase study designs, chart abstraction, and data collection.
Qualifications & Requirements
Education: Bachelor’s degree or RN in a related field (or equivalent experience).
Experience: Minimum 3–5 years of monitoring experience; Pharma background required.
Therapeutic Area: Oncology preferred; experience in Hematology, Cardiology, Neuropsychiatry, Rare Disease, Immunology is a plus.
Skills & Knowledge:
Strong knowledge of GCP/ICH guidelines and other applicable regulations
Proficient with computers and new technologies
Excellent communication, presentation, and interpersonal skills
Travel: Ability to travel up to 75% regularly
Additional Information
Tasks and responsibilities may vary at company discretion.
Equivalent experience, skills, or education may be considered.
Compliance with ADA and diversity/inclusion policies.
Expressing interest adds you to Syneos Health’s talent pipeline for upcoming opportunities.
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