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Clinical Research Associate Ii / Sr Cra - Sponsor Dedicated - Oncology (Home-Based In Western Us)

2+ years
$63,090 to $145,000
10 May 23, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Clinical Research Associate II / Sr CRA - Sponsor Dedicated - Oncology (Home-Based in Western US)
Location: United States - Home-Based
Company: Syneos Health
Job ID: 25003716
Salary: $63,090 to $145,000 per year


Job Description:

Position: Senior Clinical Research Associate I

Join Syneos Health®, a fully integrated biopharmaceutical solutions company, where you will work with over 29,000 employees across 110 countries to transform clinical development. Our culture values career progression, inclusivity, and a passion for accelerating life-changing therapies.


Key Responsibilities:

  • Monitoring Activities:
    Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remote).
    Evaluate site/staff performance and escalate issues as needed.

  • Compliance & Safety Oversight:
    Ensure GCP/ICH/GPP compliance and verify informed consent procedures.
    Assess factors impacting patient safety and data integrity.

  • Data Management:
    Conduct source document reviews and case report form (CRF) verification.
    Resolve data queries and support electronic data capture compliance.

  • Investigational Product (IP) Oversight:
    Monitor IP inventory, reconciliation, and administration per protocol.

  • Documentation & Communication:
    Maintain accurate trip reports, logs, and letters.
    Support patient recruitment strategies and enter tracking data.

  • Project Execution:
    Manage site-level timelines and deliverables.
    Act as primary site liaison and ensure team training/compliance.

  • Meetings & Audit Readiness:
    Attend sponsor meetings and staff training.
    Prepare sites for audits and implement follow-ups.

  • Mentorship & Leadership:
    Mentor junior CRAs and may assist with operational lead tasks.


Additional Real World Late Phase (RWLP) Duties:

  • Support sites from identification to closeout.

  • Conduct chart abstractions and data collection.

  • Collaborate with sponsor affiliates and suggest new sites.

  • Draft informed consent forms and participate in bid defense.


Required Qualifications:

  • Bachelor's degree or RN in a relevant field, or equivalent experience

  • Proficiency in GCP/ICH and regulatory requirements

  • Strong computer, communication, and presentation skills

  • Ability to travel up to 75%


Benefits:

  • Health benefits: Medical, Dental, Vision

  • 401(k) with company match

  • Employee Stock Purchase Plan

  • Commission/bonus eligibility

  • Flexible PTO and sick time

  • Possible car or car allowance

Syneos Health promotes a diverse, inclusive, and supportive environment with a flexible vaccination policy based on local regulations and client requirements.