About

• Responsibilities include working closely with study teams in Hamilton to ensure quality conduct of our international studies; providing regulatory training in International and National regulatory requirements related to clinical studies (e.g. ICH GCP, FDA, EMA, 21 CFR part 11, etc.) and notifying staff and management on changes to regulatory requirements. Specific knowledge and expertise is required for Computer systems validation.
• In addition this position may participate in the conduct of internal process audits; support the QA team in the coordination of external audits/regulatory inspections; review validation documents to ensure they meet regulatory requirements and industry standards; prepare and maintain records and metrics related to management of PHRI Quality Documents and CAPA implementation.

• 1. A health related degree or equivalent
• 2. Previous experience in clinical quality assurance or coordination of clinical trials/research
• 3. Excellent communication skills, both oral and written
• 4. Excellent computer skills in all Microsoft Office applications
• 5. Position ideally suited to a well-organized individual
• 6. Sound knowledge of Canadian, US, and EU regulations relevant to the conduct of clinical trials
• 7. Ability to prioritize among competing responsibilities and meet expected timelines.
• 8. Previous involvement in sponsor audits of regulatory inspections preferred