**Clinical Research Associate II / CRA I – Sponsor Dedicated (Oncology & General Medicine)
Location: Remote, Oregon, USA
Job ID: 25103340
Updated: November 14, 2025**
About the Role
Syneos Health is seeking a highly skilled Clinical Research Associate II / CRA I to support sponsor-dedicated clinical research activities across Oncology and General Medicine studies. This fully remote position (based in Western US) offers the opportunity to contribute to high-impact clinical trials within a globally recognized biopharmaceutical services organization.
As part of the Clinical Development team, you will ensure operational excellence, regulatory compliance, and high-quality data collection throughout the study lifecycle.
Key Responsibilities
Conduct site qualification, initiation, interim monitoring, and close-out visits (remote/onsite) in compliance with ICH-GCP, GPP, regulatory requirements, and internal SOPs.
Evaluate site performance, document findings, escalate critical issues, and implement corrective action plans.
Verify informed consent processes, participant safety, data integrity, and protocol adherence.
Perform Source Document Review and confirm accuracy of data entered in Case Report Forms (CRFs).
Resolve data queries and support timely data cleaning through remote and onsite techniques.
Ensure compliance with electronic data capture systems and digital tools.
Manage investigational product (IP) accountability, storage, labelling, and security.
Review Investigator Site File (ISF) and reconcile with the Trial Master File (TMF).
Prepare monitoring documentation including confirmation letters, follow-up reports, trip reports, and communication logs.
Support patient recruitment and retention strategies.
Track site-level activities, timelines, and deliverables according to project scope and budget.
Liaise with site staff, Central Monitoring Associates, sponsor representatives, and project teams.
Provide audit-readiness support and assist with audit follow-up.
Attend investigator meetings, sponsor meetings, and study-specific training sessions.
For Late Phase / Real-World Evidence studies: perform chart abstraction, site identification support, and local requirement assessments.
Mentor junior staff when assigned and identify out-of-scope activities proactively.
Qualifications & Experience Required
Bachelor’s degree in a life science discipline or RN qualification (or equivalent combination of education and experience).
Strong knowledge of ICH-GCP, regulatory guidelines, and clinical research best practices.
Minimum 2–4 years of clinical monitoring experience preferred (CRA I/CRA II level).
Proficiency in electronic clinical systems and ability to adapt to new technologies.
Excellent communication, documentation, and stakeholder management skills.
Ability to travel up to 75% as required by study protocols.
Must comply with specific US site-level medical/credentialing requirements.
Why Join Syneos Health?
Global organization with 29,000+ employees across 110 countries.
Strong commitment to professional development, technical training, and therapeutic expertise.
Supportive work culture promoting diversity, inclusion, and authenticity (Total Self Culture).
Competitive benefits including medical, dental, vision, 401(k) with company match, employee stock purchase plan, performance-based bonus, PTO, and sick leave.
Opportunities for long-term career advancement within Clinical Operations.
Salary Range
Compensation will be determined based on experience, skills, and role fit within the Syneos Health salary structure.
About Syneos Health
Syneos Health partners with leading biopharmaceutical companies and has contributed to:
94% of all FDA-approved novel drugs in the last 5 years
95% of EMA-authorized products
More than 200 clinical studies across 73,000 sites and over 675,000 trial patients
Learn more at syneoshealth.com.
Equal Opportunity Statement
Syneos Health complies with federal, state, and international employment regulations, including the ADA and EU Equality Directive. Reasonable accommodations are available upon request. Job responsibilities may evolve based on organizational needs.
Apply Now
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