Health Canada CTA Submission Associate

7 days ago

Remote, Canada 14 Premier Research Group Canada Limited Full-time

Health Canada CTA submissions define this Site Start-up Associate II role at Premier Research, requiring regulatory expertise and precise document management. Support clinical study activation across Canada.

As a Site Start-up Associate II, you prepare Health Canada CTA Applications and other required local or hospital submissions. You forecast timelines, resolve country-level EC, IRB, or CA issues, and review essential documents against sponsor, investigator, local regulatory, and ICH/GCP requirements. You also support informed consent and patient documentation.

Key Responsibilities:

  • Prepare and submit Health Canada CTA Applications
  • Forecast submission and approval timelines
  • Resolve country-level EC, IRB, or CA issues
  • Review essential documents for regulatory compliance
  • Adapt informed consent and patient document templates

Requirements:

  • Undergraduate degree in clinical, science, or health-related field
  • Three or more years of direct study start-up experience
  • Working knowledge of Health Canada submissions and regulations
  • Knowledge of country-specific clinical trial requirements
  • Ability to work independently within agreed timelines

Apply regulatory submission expertise, document review, and clinical start-up knowledge as a Health Canada CTA specialist at Premier Research.

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