Quality Assurance Coordinator

Unit Summary

Population Health Research Institute (PHRI), a joint institute of Hamilton Health Sciences and McMaster University, with over 300 employees working directly with 60 researchers. PHRI conducts clinical research internationally in 105 countries and is a world leader in large, global health and population and health outcomes research. Our capacity to conduct multiple international studies concurrently, with tens of thousands of participants in each, is a capability very few organizations in the world can match.

Position Summary

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 syste...