Instagram
youtube
Facebook

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 Clinical Research Associate (CRA)


Location:

United States (Remote)


Job ID:

2025-117745


Department:

Clinical Monitoring – ICON Strategic Solutions


Job Type:

Full-Time, Remote


Application Contact:

Name: Melissa Benner
Options: View other roles or send a direct message through the platform


Job Description:

As a Lead CRA, you will play a critical role in managing and monitoring clinical trial sites to ensure trial deliverables are met on time. This position requires advanced knowledge of clinical trial processes and excellent leadership skills to mentor junior CRAs while ensuring compliance with protocols, SOPs, ICH-GCP, and regulatory guidelines.


Key Responsibilities:

  • Apply knowledge of ICON’s policies and procedures in trial management

  • Conduct monitoring visits to ensure subject safety and data integrity

  • Provide leadership and mentorship to CRAs new to the position

  • Assist in the development of trial tools and documents

  • Serve as a leader during observation visits and contribute to client and investigator meetings

  • Assist with trial management tasks and implement process improvements

  • Ensure adherence to IP (Investigational Product) accountability

  • Identify and escalate issues related to scientific misconduct at the site level

  • Utilize Microsoft Office, CTMS, EDC, IVRS/IWRS for trial management

  • Conduct monitoring evaluations and ensure timely trial progress and database lock


Requirements:

  • Education:

    • Bachelor’s degree or equivalent required

    • Fluent in English (host country language may also be required)

  • Experience:

    • 3-5 years of clinical trial experience (in-house or site-level experience will not be considered)

    • Ability to travel (low and regional travel)

    • Proven success with fast-paced trials and database lock

    • Proficiency with clinical systems (Microsoft Office, CTMS, EDC, IVRS/IWRS)

    • Experience in monitoring all trial components (PSSV to COV) is preferred


Benefits:

  • Competitive salary and annual leave

  • Health insurance options for you and your family

  • Retirement planning with strong savings benefits

  • Global Employee Assistance Program (TELUS Health)

  • Life assurance

  • Country-specific optional benefits (childcare vouchers, gym memberships, etc.)
    🔗
    Explore ICON Benefits


Inclusion & Accessibility:

ICON fosters an inclusive environment and provides equal employment opportunities regardless of race, color, religion, gender, or disability.
🔗
Request accommodations here