Job opportunity
Health Canada CTA Submission Associate
14 Premier Research Group Canada Limited
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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Apply on source site 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.
#J-18808-Ljbffr