PHRI is seeking a Quality Assurance Coordinator (regular, full time) to join our team.
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.
- Participating in the conduct of internal process audits
- Supporting the QA team in the coordination of external audits/regulatory inspections
- Reviewing validation documents to ensure they meet regulatory requirements and industry standards
- Preparing and maintaining records and metrics related to management of PHRI Quality Documents and CAPA implementation.
Qualifications
- A health-related degree or equivalent
- Previous experience in clinical quality assurance or coordination of clinical trials/research
- Excellent communication skills, both oral and written
- Excellent computer skills in all Microsoft Office applications
- Position ideally suited to a well-organized individual
- Sound knowledge of Canadian, US, and EU regulations relevant to the conduct of clinical trials
- Ability to prioritize among competing responsibilities and meet expected timelines.
- Previous involvement in sponsor audits of regulatory inspections preferred
This is a Hamilton Health Sciences regular, full-time posting: 37.5 hours/week Monday through Friday, based in Hamilton, Ontario.
Read more and apply here: Job Number 121906
Deadline for applications: December 10, 2025, 11:59:00 PM.
