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Cra Ii / Sr Cra - Sponsor Dedicated - Oncology + Gen Med (Home-Based In Western Us)

0-2 years
Not Disclosed
10 Oct. 1, 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

Job Title:

CRA II / Sr CRA – Sponsor Dedicated (Oncology + General Medicine)
Job ID: 25102049
Location: Remote, USA – Oregon (OR)
Updated: September 25, 2025


Company Overview:

Syneos Health® is a fully integrated biopharmaceutical solutions organization accelerating customer success by translating clinical, medical affairs, and commercial insights into outcomes.

Why Syneos Health:

  • Career development and progression opportunities

  • Supportive and engaged line management

  • Technical and therapeutic area training

  • Peer recognition and total rewards program

  • Inclusive Total Self culture promoting authenticity

  • Diversity, collaboration, and belonging

Global Impact:

  • 29,000 employees across 110 countries

  • Contributed to 94% of novel FDA-approved drugs & 95% of EMA-authorized products in the last 5 years

  • Over 200 studies across 73,000 sites and 675,000+ trial patients


Role Overview:

The CRA II / Sr CRA ensures the integrity of clinical research studies through site monitoring, regulatory compliance, and data verification. This is a home-based role for Western US, focusing on oncology and general medicine studies.


Key Responsibilities:

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

  • Ensure regulatory, ICH-GCP, and protocol compliance at investigator/physician sites

  • Verify informed consent and protect subject/patient confidentiality

  • Assess factors impacting subject/patient safety and data integrity (protocol deviations, pharmacovigilance issues)

  • Conduct Source Document Review (SDR) and verify data accuracy in Case Report Forms (CRF)

  • Apply query resolution techniques and guide site staff to ensure timely closure

  • Utilize software and technology for effective clinical study data review and capture

  • Manage Investigational Product (IP) inventory, reconciliation, and compliance with protocol administration

  • Review and reconcile Investigator Site File (ISF) with Trial Master File (TMF)

  • Document activities via trip reports, follow-up letters, and communication logs

  • Support subject recruitment, retention, and awareness strategies

  • Track site activities, action items, and ongoing status using project tracking systems

  • Serve as liaison with study site personnel or Central Monitoring Associate

  • Participate in investigator and sponsor meetings, clinical training, and global project meetings

  • Ensure site audit readiness and support preparation/follow-up for audits

  • For Real World Late Phase studies: provide site support, chart abstraction, data collection, and collaborate with sponsors, affiliates, and local staff

  • Mentor junior staff and identify out-of-scope activities


Qualifications:

  • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience

  • Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and regulatory requirements

  • Strong computer skills; ability to adopt new technologies

  • Excellent communication, presentation, and interpersonal skills

  • Ability to travel up to 75% regularly

  • Must comply with site access requirements (US only)


Compensation & Benefits:

  • Base salary varies based on qualifications, skills, and proficiency

  • Benefits may include:

    • Company car or car allowance

    • Medical, dental, vision coverage

    • 401k with company match

    • Employee Stock Purchase Plan eligibility

    • Commissions/bonus opportunities

    • Flexible PTO and sick time (as per local regulations)


Summary of Role Impact:

  • Oversees clinical trials remotely to ensure compliance with protocols and regulatory standards

  • Uses risk-based monitoring and analytics to identify issues and trends

  • Collaborates with site teams to enhance monitoring quality and trial success

  • Individual contributor role; may manage small teams or processes

  • Applies professional knowledge to project components or processes within area of responsibility


Learn More:

Syneos Health

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