Clinical Research Associate II / CRA I – Sponsor Dedicated (Oncology & General Medicine)
Location: Remote – Western United States (Utah)
Job ID: 25103340
Updated: November 14, 2025
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating clinical development and improving patient outcomes worldwide. We leverage clinical, medical affairs, and commercial insights to deliver innovative solutions that meet modern healthcare demands efficiently.
Our Clinical Development model places the patient and client at the center of every decision. We continuously streamline workflows to enhance collaboration, simplify processes, and ensure excellence in clinical research. Whether in a Full-Service or Functional Service Provider (FSP) environment, our teams innovate to deliver therapies faster and improve lives globally.
Role Overview
Syneos Health is seeking a Clinical Research Associate II / CRA I to support sponsor-dedicated Oncology (ONC) and General Medicine clinical trials. This home-based position in Utah offers the opportunity to monitor clinical trial sites remotely and on-site, ensuring regulatory compliance, patient safety, and high-quality data collection.
The successful candidate will be highly organized, proactive, and capable of collaborating with cross-functional teams while supporting patient recruitment and retention strategies.
Key Responsibilities
Conduct site qualification, initiation, interim monitoring, and close-out visits (remote or on-site) in compliance with ICH-GCP, GPP, local regulations, and study protocols.
Evaluate site performance, identify risks, escalate critical issues, and implement corrective action plans.
Verify proper informed consent procedures and maintain patient confidentiality. Monitor patient safety and data integrity.
Perform source document verification and confirm accuracy of case report form (CRF) data.
Apply query resolution techniques, guide site staff, and ensure timely closure of data issues.
Manage investigational product (IP) accountability, including storage, reconciliation, labeling, import/export, and blinded/randomized protocols.
Maintain Investigator Site Files (ISF) and reconcile with Trial Master File (TMF) according to regulatory requirements.
Document site activities through trip reports, follow-up letters, communication logs, and other project documentation.
Support patient recruitment, retention, and awareness strategies.
Serve as primary liaison with site personnel and collaborate with Central Monitoring Associates as needed.
Participate in investigator meetings, sponsor meetings, and required clinical training sessions.
Ensure audit readiness at site and project level, supporting follow-up actions.
For Real-World Late Phase studies, provide site lifecycle support, chart abstraction, and collaboration with sponsor affiliates and local staff.
Mentor junior staff and proactively suggest potential sites based on local treatment patterns and healthcare provider networks.
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Nursing (RN), Pharmacy, or related field.
CRA I: Minimum 1 year of clinical monitoring experience.
CRA II: Minimum 2–4 years of independent clinical monitoring experience.
Strong knowledge of ICH-GCP Guidelines, SOPs, and clinical research regulations.
Proficiency with electronic data capture (EDC) systems and clinical monitoring tools.
Excellent communication, presentation, and interpersonal skills.
Ability to manage up to 75% travel, including remote and on-site visits.
Preferred Qualifications
Experience in Oncology and General Medicine clinical trials.
Familiarity with risk-based monitoring and real-world evidence studies.
Experience mentoring junior clinical staff.
Compensation & Benefits
Competitive salary based on experience and qualifications.
Health benefits: Medical, Dental, Vision.
Retirement: 401(k) match and Employee Stock Purchase Plan.
Performance-based bonuses and incentive programs.
Flexible paid time off (PTO) and sick leave.
Company car or car allowance (if applicable).
Why Join Syneos Health?
Contribute to global clinical trials impacting over 675,000 patients across 73,000 sites.
Work in a diverse, inclusive, and supportive environment.
Access continuous career development, mentoring, and training programs.
Join a forward-thinking organization dedicated to accelerating innovative therapies.
Additional Information
This description is not exhaustive. Additional responsibilities may be assigned as needed. Equivalent education, skills, or experience may also be considered. Syneos Health complies with all employment laws, including the Americans with Disabilities Act (ADA).
Apply Now to join a leading global clinical research team or join our Talent Network for updates on future opportunities.
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