Clinical Research Associate II / CRA I – Sponsor Dedicated (Oncology & General Medicine)
Location: Remote – Western United States (Montana)
Job ID: 25103340
Updated: November 14, 2025
Company Overview
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating clinical development and improving patient outcomes globally. We combine clinical, medical affairs, and commercial expertise to deliver innovative solutions addressing modern healthcare challenges.
Our Clinical Development model centers the patient and client, continuously optimizing processes to simplify collaboration and ensure excellence in clinical trials. Team members work in Full-Service or Functional Service Provider (FSP) environments, driving innovation, efficiency, and successful therapy delivery.
Position Summary
We are seeking an experienced Clinical Research Associate II / CRA I to provide sponsor-dedicated support for Oncology (ONC) and General Medicine trials. This remote, home-based role in Montana involves monitoring trial sites, ensuring regulatory compliance, protecting patient safety, and verifying data integrity. The role requires a proactive professional capable of collaborating with cross-functional teams and mentoring junior staff when necessary.
Key Responsibilities
Conduct site qualification, initiation, interim monitoring, and close-out visits, both remotely and on-site, ensuring compliance with ICH-GCP, GPP, local regulations, and study protocols.
Evaluate site and staff performance; escalate critical issues; and implement corrective action plans.
Verify informed consent procedures and maintain patient confidentiality. Monitor safety and clinical data quality.
Perform source document verification and ensure case report forms (CRFs) are accurate and complete.
Lead query resolution processes and guide site staff to ensure timely closure.
Manage investigational product (IP) accountability, including storage, reconciliation, labeling, and adherence to blinded/randomized protocols.
Maintain Investigator Site Files (ISF) and reconcile with Trial Master File (TMF).
Document activities via trip reports, follow-ups, and other project records.
Support patient recruitment, retention, and site awareness initiatives.
Act as liaison with study site personnel and collaborate with Central Monitoring Associates.
Participate in investigator and sponsor meetings, as well as project-specific clinical training sessions.
Provide guidance on audit readiness and support audits as required.
For Real-World Late Phase studies, assist in site lifecycle support, chart abstraction, and local collaboration with sponsor affiliates.
Mentor junior staff and provide local site insights to optimize study conduct.
Qualifications & Experience
Bachelor’s degree or RN in Life Sciences, Nursing, 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 understanding of ICH-GCP Guidelines, SOPs, and regulatory requirements.
Proficiency with electronic data capture (EDC) systems and clinical monitoring software.
Excellent communication, presentation, and interpersonal skills.
Ability to travel up to 75%, including on-site visits.
Preferred
Experience in Oncology and General Medicine clinical trials.
Knowledge of risk-based monitoring and real-world evidence studies.
Experience mentoring junior clinical staff.
Compensation & Benefits
Competitive salary based on qualifications and experience.
Comprehensive health benefits: Medical, Dental, Vision.
401(k) match and Employee Stock Purchase Plan eligibility.
Performance-based bonus opportunities.
Flexible paid time off (PTO) and sick leave.
Company car or allowance where applicable.
Why Join Syneos Health?
Work with over 675,000 patients across 73,000 sites globally.
Engage in a diverse, inclusive, and supportive work culture.
Access career development, mentoring, and training programs.
Contribute to cutting-edge clinical research that transforms patient outcomes.
Additional Information
This description is not exhaustive. Duties may evolve, and equivalent experience or education will also be considered. Syneos Health is committed to compliance with the Americans with Disabilities Act (ADA) and provides reasonable accommodations where appropriate.
Apply Now to join a global leader in clinical research, or join our Talent Network for updates on future opportunities.
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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