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Clinical Research Associate - Oncology

2-5 years
Not Disclosed
10 April 18, 2025
Job Description
Job Type: Full Time Remote 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 – Oncology (West, USA - Remote)


Location:

Remote – United States (West region)


Job ID:

2025-118411


Department:

Clinical Monitoring – ICON Strategic Solutions


Job Type:

Full-Time, Remote


Application Contact:

Name: Monica Hawkins
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Job Description:

As a Clinical Research Associate (CRA), you will work with oncology trials ensuring high-quality execution. The role involves performing clinical trial monitoring activities, including site startup, regulatory document collection, informed consent review, trial management, and issue resolution.


Key Responsibilities:

  • Implement and monitor clinical trials in compliance with ICH GCP guidelines

  • Oversee site startup activities such as regulatory documentation, informed consent, and IRB/IEC submission

  • Manage clinical data, ensuring accuracy during monitoring visits (onsite or remote)

  • Escalate trial-related issues to resolve concerns in a timely manner

  • Perform source document verification, query resolution, and IP accountability at investigative sites

  • Lead site and performance visits and serve as the subject matter expert for monitoring activities

  • Verify serious adverse event (SAE) reporting per ICH GCP

  • Update applicable tracking systems and manage training completion for the team


Required Qualifications:

  • Location: Must be based in the United States (West region)

  • Degree: Undergraduate in a clinical, science, or health-related field, or equivalent work experience

  • Experience:

    • 2-5 years clinical monitoring experience (CRA 2)

    • 5+ years clinical monitoring experience (Sr CRA)

  • Proficiency in site feasibility, selection, and startup

  • Experience in budget negotiations (preferred)

  • Strong knowledge of ICH guidelines, GCP, and local regulatory requirements

  • Excellent written and spoken English

  • Applicants must be legally authorized to work in the U.S. without future sponsorship


What ICON Offers:

  • Competitive salary and performance rewards

  • Comprehensive health insurance and family support

  • Retirement planning and savings opportunities

  • Employee Assistance Program (TELUS Health) for 24/7 support

  • Paid leave, health assessments, and other flexible benefits
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Diversity & Inclusion Commitment:

ICON is dedicated to fostering an inclusive, diverse workplace with equal opportunity for all candidates, free from discrimination or harassment.