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Cra Ii - In-Vitro Diagnostics

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

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Job Title:

CRA II - In-Vitro Diagnostics


Location:

Boston, MA or Tucson, AZ, United States (Remote)


Job ID:

2024-109188


Department:

Clinical Monitoring – ICON Strategic Solutions


Job Type:

Full-Time, Remote


Application Contact:

Name: Jamie Pruitt
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Job Description:

As a Clinical Research Associate II focused on In-Vitro Diagnostics (IVD), you will oversee and execute clinical research studies, ensuring compliance with GCP, FDA, and IVD regulations. Your role will involve collaborating with labs, leading site interactions, and supporting regulatory submission efforts.


Key Responsibilities:

  • Conduct and document clinical trials in accordance with GCP, FDA, and IVD guidelines

  • Lead site selection, initiation, monitoring, and close-out visits

  • Validate product performance and contribute to regulatory submissions

  • Collect site and lab feedback from investigators and key opinion leaders

  • Collaborate on post-launch clinical activities and cross-functional initiatives


Requirements:

  • Experience:

    • Minimum of 5 years as a CRA

    • In-vitro diagnostics (IVD) experience preferred

    • Leadership or supervisory experience is a plus

  • Education:

    • Bachelor’s degree in a relevant field (e.g., Medical Technology or R&D)

    • CRA certification is a plus

  • Skills:

    • Excellent communication, organizational, and leadership skills

    • Proficient in Microsoft Word and Excel

    • Basic knowledge of statistics

    • Ability to work independently and problem-solve effectively


Benefits:

  • Competitive salary and various annual leave options

  • Health insurance tailored to family needs

  • Retirement planning support

  • Global Employee Assistance Program via TELUS Health

  • Life assurance and wellness-focused benefits

  • Optional benefits including childcare vouchers, gym discounts, travel subsidies, and more
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Inclusion & Accessibility:

ICON promotes a diverse and inclusive culture, providing equal opportunity to all qualified applicants and supporting individuals who require reasonable accommodations.
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