Clinical Research Associate II / CRA I – Sponsor Dedicated (Oncology & General Medicine) – Remote, Western USA
Location: Western United States (Home-based)
Job Type: Full-Time
Updated: November 14, 2025
Job ID: 25103340
Company: Syneos Health
Experience Required: 2–4 years of clinical monitoring or CRA experience preferred
About the Role
Syneos Health is seeking a Clinical Research Associate II / CRA I to support sponsor-dedicated clinical research projects across Oncology and General Medicine. This is a remote position based in the Western United States. The role involves conducting site qualification, initiation, monitoring, and close-out activities in alignment with ICH-GCP, regulatory standards, and study protocols.
You will work within a global team committed to accelerating clinical development and improving patient outcomes. This position demands adaptability, strong communication skills, and the ability to manage up to 75% travel.
Key Responsibilities
Clinical Site Monitoring
Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote).
Ensure compliance with ICH-GCP, GPP, regulatory guidelines, and sponsor protocols.
Evaluate site performance, identify risks, and escalate critical issues promptly.
Verify informed consent documentation and ensure subject confidentiality.
Data Review & Documentation
Conduct Source Document Review and verify the accuracy of Case Report Forms (CRFs).
Resolve queries and ensure timely data entry in Electronic Data Capture systems.
Maintain Investigator Site File (ISF) accuracy and ensure alignment with the Trial Master File (TMF).
Document all site activities through confirmation letters, follow-up reports, trip reports, and logs.
Investigational Product Oversight
Perform investigational product (IP) inventory checks and reconcile records.
Confirm IP labeling, storage, dispensing, and administration processes meet regulatory standards.
Project Coordination
Manage site-level project activities to support timelines and deliverables.
Attend investigator meetings, sponsor meetings, and clinical training sessions.
Support recruitment and retention strategies.
Provide guidance toward audit readiness and assist with regulatory audits.
Additional Responsibilities (Real World Late Phase Studies)
Support RWE site activities from identification to close-out.
Perform chart abstraction and data collection.
Collaborate with sponsor affiliates, medical science liaisons, and country teams.
Train junior team members as needed.
Qualifications
Bachelor’s degree in Life Sciences, Nursing (RN), Pharmacy, or a related field.
Strong knowledge of ICH-GCP and regulatory guidelines.
Proficiency in clinical research technologies and monitoring tools.
Excellent communication, organizational, and interpersonal skills.
Ability to travel up to 75% regularly.
US Candidates: Certain sites may require medical or personal information for access. Compliance with these requirements is mandatory.
Compensation & Benefits
Syneos Health offers competitive compensation based on experience, skills, and role fit. Benefits may include:
Company car or car allowance
Medical, Dental, and Vision coverage
401(k) with company match
Employee Stock Purchase Plan eligibility
Performance-based bonuses or commissions
Flexible paid time off and sick leave (varies by state)
Why Join Syneos Health
Syneos Health has supported:
94% of novel FDA-approved drugs in the past 5 years
95% of EMA-authorized products
Over 200 clinical studies across 73,000 sites and 675,000+ trial patients
You will be part of a global environment that values diverse perspectives, fosters professional growth, and empowers individuals to innovate and challenge the status quo.
Application
If you are driven, detail-oriented, and passionate about advancing clinical research, apply now. Candidates with transferable skills are encouraged to apply.
Apply now or join the Talent Network to explore future opportunities.
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Frank Scottile Blvd |Missouri :
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Sheffield |Oxfordshire :
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Canada |Quebec :
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Zaventem |South America :
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Greece |North Island :
Auckland |New Zealand :
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