Senior Clinical Research Associate – Oncology

Posted 56ds ago

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Job Description

Senior Clinical Research Associate managing site monitoring and clinical trial execution in Canada. Ensuring compliance with good practices and regulations during clinical studies.

Responsibilities:

  • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
  • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
  • Serve as the primary point of contact for assigned investigator sites during study conduct
  • Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit
  • Submit all required reports, documentation, updates and tracking within required timeframes

Requirements:

  • Minimum 3 years relevant experience in clinical research site monitoring at a CRO or pharma organization (preferably 2 years in Oncology)
  • Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
  • Must be fluent in English and in the native language(s) of the country they will work in

Benefits:

  • Complies with required training curriculum
  • Completes timesheets accurately as required
  • Submits expense reports as required
  • Updates Curriculum Vitae (CV) as required
  • Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements