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

2-4 years
Not Disclosed
10 Nov. 27, 2025
Job Description
Job Type: 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 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.