Clinical Research Associate II / CRA I – Oncology & General Medicine (Remote, Western US)
Location: USA – CO – Remote
Updated: November 14, 2025
Job ID: 25103340
Overview
Syneos Health, a leading global biopharmaceutical solutions organization, is seeking a Clinical Research Associate II / CRA I to support oncology and general medicine studies in a sponsor-dedicated model. This remote position is based in the Western United States and plays a critical role in advancing clinical development through high-quality monitoring and site management.
With a presence in more than 110 countries and over 29,000 employees, Syneos Health focuses on accelerating clinical and commercial success for customers through integrated, patient-centric solutions.
Key Responsibilities
Conduct site qualification, initiation, routine monitoring, and close-out visits both on-site and remotely.
Ensure compliance with ICH-GCP, GPP, regulatory requirements, and study protocols.
Evaluate site performance, identify issues, escalate risks, and contribute to corrective action planning.
Verify informed consent documentation, protect participant confidentiality, and identify safety concerns or protocol deviations.
Review medical records and source documents; validate accuracy of case report forms (CRFs).
Perform data review and query resolution using clinical data systems and electronic data capture platforms.
Oversee investigational product (IP) accountability, storage, security, and reconciliation.
Maintain and reconcile Investigator Site Files and Trial Master File documentation.
Create monitoring reports, follow-up letters, communication records, and project documentation per SOPs.
Support patient recruitment and site engagement strategies.
Manage site-level deliverables, communication, and adherence to project timelines.
Serve as the primary contact for assigned sites and collaborate with central monitoring teams.
Participate in investigator meetings, sponsor meetings, and global team training sessions.
Contribute to audit readiness and support post-audit corrective actions.
For Real-World/Late Phase studies: conduct chart abstraction, coordinate local requirements, and collaborate with affiliates and medical liaisons.
May provide training or mentorship to junior team members.
Qualifications and Experience Required
Bachelor’s degree in a scientific field or RN qualification; equivalent education/experience will be considered.
Minimum Experience Requirement:
CRA I: Approximately 1+ year of independent monitoring experience.
CRA II: Typically 2+ years of independent on-site monitoring experience in clinical research.
Solid understanding of ICH-GCP and applicable regulatory guidelines.
Proficiency with clinical trial software, EDC systems, and digital platforms.
Strong communication, presentation, and interpersonal skills.
Ability to travel up to 75%, depending on site and study requirements.
Must comply with site-specific credentialing or medical access requirements in the United States.
Why Join Syneos Health
Career progression pathways, technical skill development, and therapeutic-area training.
Supportive leadership and a culture of authenticity through the company’s Total Self initiative.
Recognition programs, global collaboration, and an environment built to support professional growth.
Competitive total rewards program, including health benefits, 401(k) company match, stock purchase plan eligibility, performance-based incentives, and flexible paid time off.
Compliance with all federal, state, and municipal regulations regarding paid sick leave.
Salary Range
The compensation range reflects Syneos Health’s anticipated base salary low-to-high range for this role. Actual salary will depend on skills, experience, competencies, and role-related factors.
About Syneos Health
In the past five years, Syneos Health has contributed to 94 percent of all newly FDA-approved drugs and 95 percent of EMA-authorized products. With more than 200 studies conducted across 73,000 sites and over 675,000 trial participants, the organization plays a significant role in shaping the future of clinical research and commercialization.
Learn more at SyneosHealth.com.
Additional Information
Responsibilities listed above are not exhaustive and may be adjusted by the company.
Equivalent qualifications may be accepted based on organizational discretion.
Syneos Health adheres to the Americans with Disabilities Act and provides reasonable accommodations where needed.
This job description complies with global employment legislation and the EU Equality Directive.
Summary
The Clinical Research Associate II / CRA I role ensures high-quality oversight of clinical trials by monitoring data integrity, site performance, and regulatory compliance. This position contributes significantly to risk-based monitoring strategies, process optimization, and successful study delivery. It is suitable for professionals with practical clinical research experience and strong technical competency.
Apply Now
Interested candidates may submit an application online.
Not ready to apply? Join the Syneos Health Talent Network to receive updates on future opportunities.
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