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Clinical Research Associate-Contractor

2 months ago

Toronto, Ontario, Canada Tigermed Full time
Job Summary

We are seeking a highly skilled Clinical Research Associate to join our team at Tigermed. As a Clinical Research Associate, you will be responsible for managing clinical studies from site selection to close-out, ensuring high-quality data and compliance with regulatory requirements.

Key Responsibilities
  • Study Site Management
    • Identify and select suitable study sites, ensuring they meet sponsor criteria.
    • Conduct site initiation visits to ensure site staff understand study protocols and requirements.
    • Monitor study progress, addressing any issues that arise and completing monitoring visit reports in a timely manner.
    • Ensure timely coordination of study materials and equipment to sites.
    • Assemble and submit site-specific EC dossiers.
  • Drug Safety
    • Ensure safety information is disseminated to all sites according to SOPs and regulations.
    • Report Serious Adverse Events (SAEs) within the required timeline.
  • Finance and Administration
    • Finalize budgets and obtain signed contracts from sites prior to site initiation visits.
    • Ensure Study Payment Schedules are executed and relevant documents are retained.
  • Study Tools and Systems
    • Update and maintain study tools and systems in a timely manner.
Requirements
  • Bachelor's degree or above in a medical, pharmacology, or biology-related field.
  • At least 3 years of CRA experience.
  • Exceptional written and verbal skills in French and English.
  • Good understanding and knowledge of Good Clinical Practice and clinical trial operations.
  • Proficiency in Microsoft Office applications, including Word, Excel, and Outlook.