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Senior Cra - Bilingual

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:

Senior Clinical Research Associate (CRA) – Bilingual (French/English)


Location:

Canada (Remote – covering sites in Ontario and Quebec)


Job ID:

2025-117365


Department:

Clinical Monitoring (ICON Strategic Solutions)


Job Type:

Full-Time, Remote


Application Contact:

Name: Jamie Pruitt
Message Option: Available via the job platform
View Roles: See Jamie’s other open roles


Job Description:

ICON plc is a global leader in healthcare intelligence and clinical research. The organization is dedicated to creating an inclusive environment that fosters innovation and excellence in the field of clinical development.


Key Responsibilities:

  • Act as primary site contact, ensuring smooth communication between the trial team and sites

  • Conduct and document on-site and remote monitoring visits (SQV, SIV, IMV, COV)

  • Maintain inspection readiness and oversee essential document collection and TMF reconciliation

  • Lead training sessions to ensure site adherence to protocol, SOPs, GCP, and regulations

  • Support sites during regulatory inspections and IRB/EC submissions

  • Monitor Key Risk Indicators (KRIs), identify trends, and implement CAPA plans

  • Mentor junior CRAs and participate in quality oversight activities

  • Engage sites through feasibility, qualification, activation, and close-out stages

  • Foster strong relationships with oncology sites and networks


Qualifications & Experience:

  • Education:

    • Bachelor’s degree in a scientific discipline preferred

  • Experience:

    • 5+ years independently monitoring oncology clinical trials (site visits and remote)

    • 1+ year in early development clinical trials

    • Solid tumor experience preferred

    • Experience with Veeva systems is a plus

    • Proven record of site compliance and relationship building

    • Knowledge of Risk-Based Monitoring and GCP

    • Experience in training site staff and supporting during inspections

    • Familiarity with FSP or in-house monitoring models preferred

  • Other Requirements:

    • Bilingual in French and English

    • Willingness to travel up to 50%


Benefits Offered by ICON:

  • Competitive salary and retirement savings plans

  • Flexible, country-specific benefits (e.g., childcare vouchers, gym memberships)

  • Multiple health insurance options

  • Annual leave entitlements

  • Global Employee Assistance Program (TELUS Health)

  • Life assurance

  • Strong focus on work-life balance and employee well-being
    🔗
    ICON Careers – Benefits


Diversity & Accessibility Statement:

ICON embraces diversity and is committed to creating an inclusive, accessible workplace.
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