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

0-2 years
Not Disclosed
10 Nov. 27, 2025
Job Description
Job Type: Full Time Remote 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) – Remote, Western US

Location: USA – Idaho (Remote)
Job ID: 25103340
Updated: November 14, 2025
Position Type: Full-Time
Company: Syneos Health®

About the Company

Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. The organization unites clinical, medical affairs and commercial capabilities to deliver results aligned with evolving market needs. With more than 29,000 employees across 110 countries, Syneos Health is recognized for driving innovation and supporting the development of life-changing therapies.

Role Overview

Syneos Health is seeking a Clinical Research Associate II / CRA I to support Oncology and General Medicine studies in a sponsor-dedicated model. This is a home-based role in the Western US, responsible for clinical site monitoring, ensuring compliance with ICH-GCP guidelines, regulatory requirements, and protocol standards.

The position involves remote and on-site monitoring activities, site management, risk-based monitoring, data review, and collaboration with study site personnel to ensure study quality and operational efficiency.

Key Responsibilities

  • Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remote).

  • Ensure compliance with ICH-GCP, GPP, regulatory guidelines, and study protocols.

  • Evaluate site performance, identify issues, and implement corrective actions.

  • Verify informed consent procedures and protect patient confidentiality.

  • Perform Source Document Review, validate CRF data accuracy, and drive query resolution.

  • Ensure compliance with electronic data capture systems and study tools.

  • Handle investigational product (IP) accountability, storage review, and reconciliation.

  • Maintain and reconcile the Investigator Site File with the Trial Master File.

  • Prepare monitoring reports, follow-up letters, and documentation as per SOPs.

  • Support patient recruitment, retention, and site engagement strategies.

  • Track observations, timelines, and action items in relevant systems.

  • Act as a primary liaison with study sites, ensuring readiness and training compliance.

  • Participate in investigator meetings, sponsor meetings, and monitoring team discussions.

  • Support audit readiness and assist in follow-up of audit actions.

  • For Real World Late Phase studies: conduct chart abstraction, collaborate with sponsor affiliates, train junior staff, and recommend new sites based on local insights.

Required Qualifications

  • Bachelor’s degree in a related field or RN qualification.

  • Strong knowledge of ICH-GCP and applicable regulatory guidelines.

  • Proficiency in digital tools, clinical systems, and modern technologies.

  • Excellent interpersonal, communication, and presentation skills.

  • Ability to travel up to 75% regularly.

  • Must comply with site-specific access requirements, including health or personal information where applicable (US-based requirement).

Compensation and Benefits

Syneos Health offers competitive compensation and a comprehensive benefits package, which may include:

  • Company car or car allowance

  • Medical, dental, and vision benefits

  • 401(k) with company match

  • Employee Stock Purchase Plan eligibility

  • Performance-based commissions or bonuses

  • Flexible paid time off (PTO) and sick leave (state-specific variations apply)

Salary:
The salary range will vary based on candidate experience, skills, and qualifications.

Why Join Syneos Health?

  • Ongoing learning, career development, and recognition programs

  • Supportive leadership and collaborative culture

  • Commitment to diversity, inclusion, and authentic workplace values

  • Access to global clinical expertise and industry-leading resources

  • Contribution to meaningful clinical research impacting patient lives

Additional Information

Responsibilities listed are not exhaustive and may evolve based on organizational and project needs. Syneos Health adheres to all equal employment opportunity laws and provides reasonable accommodations under the Americans with Disabilities Act (ADA).