Quality Assurance Coordinator

Unit SummaryThe 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 SummaryPosition SummaryResponsibilities 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.Schedule Work HoursMonday-Friday; 37.5 hoursQualifications1. A health related degree or equivalent2. Previous experience in clinical quality assurance or coordination of clinical trials/research3. Excellent communication skills, both oral and written4. Excellent computer skills in all Microsoft Office applications5. Position ideally suited to a well-organized individual6. Sound knowledge of Canadian, US, and EU regulations relevant to the conduct of clinical trials7. Ability to prioritize among competing responsibilities and meet expected timelines.8. Previous involvement in sponsor audits of regulatory inspections preferredHamilton Health Sciences fosters a culture of patient and staff safety, whereby all employees are guided by our Mission, Vision, Values, and Values Based Code of Conduct. Hamilton Health Sciences is a teaching hospital and all staff and physicians are expected to support students and other learners.To be considered for this opportunity applicants must apply during the posting period. All internal and external applicants may ONLY apply via the Careers website.Hamilton Health Sciences is an equal opportunity employer and we will accommodate any needs under the Canadian Charter of Rights and Freedom, Accessibility for Ontarians with Disabilities Act and the Ontario Human Rights Code. Hiring processes will be modified to remove barriers to accommodate those with disabilities, if requested. Should any applicant require accommodation through the application processes, please contact HR Operations at 905-521-2100, Ext. 46947 for assistance. If the applicant requires a specific accommodation because of a disability during an interview, the applicant will need to advise the hiring manager when scheduling the interview and the appropriate accommodations can be made.This competition is open to all qualified applicants, however, qualified internal applicants will be considered first. Past performance will be considered as part of the selection process. If you are a previous employee of Hamilton Health Sciences, please note: the circumstances around an employee's exit will be considered prior to an offer of employment. Proficiency in both Official Languages, French and English, is considered an asset.