Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With a workforce of 29,000+ employees across 110 countries, Syneos Health combines clinical, medical affairs, and commercial expertise to deliver impactful outcomes in today’s dynamic market.
Our Clinical Development model prioritizes patients and customers, ensuring streamlined processes that enhance efficiency and collaboration. Whether in Functional Service Provider (FSP) partnerships or Full-Service engagements, our teams work passionately to bring life-changing therapies to market faster.
Why Join Syneos Health?
- Career Growth: Continuous learning, leadership development, and career progression opportunities.
- Inclusive Culture: A Total Self culture where authenticity and diversity thrive.
- Global Impact: Work on groundbreaking studies—94% of FDA-approved novel drugs in the past 5 years involved Syneos Health.
- Flexibility & Support: Engaged leadership, technical training, and work-life balance initiatives.
Job Description: Clinical Research Associate II (CRA II)
Key Responsibilities
- Conduct site qualification, initiation, monitoring, and close-out visits (onsite/remote), ensuring ICH-GCP, regulatory, and protocol compliance.
- Verify informed consent documentation, patient safety, and data integrity.
- Perform source document review (SDR), case report form (CRF) verification, and query resolution.
- Manage investigational product (IP) inventory, reconciliation, and storage compliance.
- Maintain Investigator Site Files (ISF) and Trial Master File (TMF) alignment.
- Support subject recruitment, retention strategies, and audit readiness.
- Act as a primary site liaison, ensuring training and compliance.
- Attend Investigator Meetings and contribute to project discussions.
Additional Responsibilities for Real-World Late Phase Studies (Site Management Associate II – SMA II)
- Support site identification, chart abstraction, and data collection.
- Collaborate with Sponsor affiliates, medical science liaisons, and local teams.
- Train junior staff and identify out-of-scope activities.
Qualifications & Requirements
✅ Experience: Minimum 3 years as an onsite CRA in clinical research.
✅ Therapeutic Expertise: Preferred in Oncology, Neurology, or Cardiology.
✅ Education: Bachelor’s degree or RN in a related field (or equivalent experience).
✅ Regulatory Knowledge: Strong understanding of ICH-GCP, GPP, and local regulations.
✅ Technical Skills: Proficiency in eClinical tools, EDC systems, and remote monitoring technologies.
✅ Travel: Willingness to travel up to 75% as needed.
✅ Soft Skills: Excellent communication, problem-solving, and organizational abilities.
