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Clinical Research Associate Ii / Cra I - Sponsor Dedicated - Onc + Gen Med (Home-Based In Western Us)

1-2 years
Not Disclosed
10 Nov. 19, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Research Associate II / CRA I – Sponsor Dedicated (Oncology & General Medicine)

Location: Remote – Western United States (Washington State)
Job ID: 25103340
Updated: November 14, 2025

Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating clinical development and improving patient outcomes globally. By leveraging expertise in clinical, medical affairs, and commercial insights, Syneos Health delivers innovative solutions that meet modern healthcare challenges efficiently.

Our Clinical Development model centers on the patient and client experience, optimizing trial execution while simplifying workflows for both our customers and employees. Whether you join us in a Full-Service or Functional Service Provider (FSP) environment, you will collaborate with high-performing teams to drive impactful clinical results.

Role Summary

Syneos Health is seeking an experienced Clinical Research Associate II / CRA I for sponsor-dedicated Oncology (ONC) and General Medicine trials. This home-based role in Washington State is responsible for monitoring clinical trial sites remotely and on-site, ensuring protocol compliance, patient safety, and high-quality data collection.

The ideal candidate is detail-oriented, organized, and capable of managing multiple sites while maintaining strong communication with cross-functional teams and 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, Good Pharmacoepidemiology Practice (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 ensure clinical data integrity.

  • Perform source document verification and confirm accuracy of case report form (CRF) data.

  • Resolve queries remotely or on-site, guide site staff, and ensure timely closure of data issues.

  • Manage investigational product (IP) accountability, including storage, reconciliation, labeling, import/export, and adherence to 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 required project documentation.

  • Support patient recruitment, retention, and awareness strategies.

  • Act as 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 the site and project level and support follow-up actions.

  • For Real-World Late Phase studies, provide site lifecycle support, chart abstraction, and collaborate with sponsor affiliates, medical science liaisons, and local country staff.

  • Mentor junior staff and recommend 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 systems and clinical monitoring technologies.

  • Excellent communication, presentation, and interpersonal skills.

  • Ability to manage travel up to 75%, including remote and on-site visits.

Preferred Qualifications

  • Experience in Oncology and General Medicine clinical trials.

  • Familiarity with risk-based monitoring, real-world evidence studies, and patient recruitment strategies.

  • Experience mentoring junior clinical staff.

Compensation & Benefits

  • Competitive salary based on experience and qualifications.

  • Health benefits: Medical, Dental, Vision.

  • Retirement benefits: 401(k) match and Employee Stock Purchase Plan.

  • Performance-based bonus opportunities.

  • 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.

  • Thrive in a diverse, inclusive, and supportive work environment.

  • Access continuous career development, training, and mentoring opportunities.

  • Work remotely while playing a critical role in accelerating innovative therapies.

Additional Information

This description is not exhaustive; additional responsibilities may be assigned as required. Equivalent education, skills, or experience may be considered. Syneos Health complies with all applicable employment laws, including the Americans with Disabilities Act (ADA) and equal opportunity regulations.

Apply Now to join Syneos Health’s global clinical research team or join our Talent Network to stay informed about future opportunities.