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Lead Cra

3-5 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:

Lead CRA (Clinical Research Associate)


Location:

United States (Remote)


Job ID:

2025-117746


Department:

Clinical Monitoring – ICON Strategic Solutions


Job Type:

Full-Time, Remote


Application Contact:

Name: Melissa Benner
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Job Description:

As a Lead CRA, you will play a critical leadership role in overseeing site monitoring activities to ensure trial integrity, compliance, and subject safety across all trial phases. You will also mentor junior CRAs and contribute to process development, documentation, and training initiatives.


Key Responsibilities:

  • Apply ICON’s policies and ICH/GCP guidelines in trial operations

  • Monitor investigative sites to ensure compliance and subject safety

  • Escalate issues appropriately and in a timely manner

  • Manage investigational product (IP) accountability and detect scientific misconduct

  • Utilize CTMS, IVRS/IWRS, EDC platforms, and Microsoft Office efficiently

  • Lead observational visits and CRA evaluations

  • Assist with CTM (Clinical Trial Manager) tasks and trial documentation

  • Present at client/investigator meetings and lead internal training

  • Contribute to trial process improvements and document development


Requirements:

  • Education:

    • Bachelor’s degree (Life Sciences preferred)

  • Experience:

    • 3–5 years of clinical trial monitoring experience

    • In-house or site-level-only experience not considered

    • Proven ability to manage fast-paced trials with rapid turnaround

    • Skilled in all trial phases (PSSV to COV) preferred

    • High proficiency with Microsoft Office and clinical systems

    • Fluent in English and host country language

    • Willingness to travel (frequency discussed during screening)


Benefits:

  • Competitive salary package

  • Annual leave entitlements

  • Flexible health insurance plans

  • Retirement savings support

  • TELUS Health global well-being access (24/7)

  • Life assurance

  • Additional optional benefits: gym memberships, childcare vouchers, travel subsidies, health assessments
     
    More on ICON Benefits


Inclusion & Accessibility:

ICON is committed to inclusivity, accessibility, and equal opportunity employment.
Request reasonable accommodations