Clinical Research Coordinator - Ethics & Regulatory Affairs (Montreal)

Clinical Research Coordinator - Ethics & Regulatory Affairs (Montreal)

03 Oct
|
RI-MUHC | Research Institute of the MUHC | #rimuhc
|
Montreal

03 Oct

RI-MUHC | Research Institute of the MUHC | #rimuhc

Montreal

Do you want to work for a world-renowned research institute that pushes the boundaries of biomedical science and health research? At the Research Institute of the McGill University Health Centre (RI-MUHC), you can be part of an organization focused on scientific discovery and innovation in patient-centered medicine. RESEARCH INSTITUTE OF THE MUHC The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and hospital research centre.

Located in Montreal, Quebec, the Institute is the research arm of the McGill University Health Centre (MUHC) affiliated with the Faculty of Medicine at McGill University. The RI-MUHC is supported in part by the Fonds de recherche du Québec - Santé (FRQS).

Department / Research Program: CVIS Research The Chronic Viral Illness Service Research team has an active research program, conducting numerous clinical trials each year to provide creative research to their patients. Under the immediate supervision of the CVIS Research Director and the CVIS Clinical Research Manager, the incumbent will be directly involved in several PI-Initiated and industry clinical trials and research studies, related to chronic viral illnesses such as HIV, HBV, HCV, STIs, and liver diseases.

The Clinical Research

Coordinator – Ethics & Regulatory Affairs will complete the below listed tasks at the Chronic Viral Illness Service of the McGill University Health Center. Collaborates with internal (Researchers, research staffs, pharmacy, Research institution department, Quality Assurance, Hospital department and Division, clinic staff) and external ( CATALIS, other research sites, Pharmaceutical Industry Sponsor, CROs, etc.) Primary point of contact for research ethics committees,



Organize Site Initiation Visit, Regulatory affairs activities Act as a resource for investigators and research staff on clinical trials regulations, GCP, HCD5, SOPs, etc., Maintain Regulatory documentation and Investigator Site Files (ISF), Maintain research team regulatory certifications and Master Regulatory files, Assure timely completion and signatures of regulatory documents for trials, Prepare training synopsis & training logs for trials initiation and amendments, Organize Site Initiation Visits, and other trials trainings, Follow-up/meet with the CRA during/after monitoring visits, Assist with Investigator Initiated Study ethics and regulatory affairs, MSSS multicentric submission with other sites in Quebec, Comply with Good Clinical Practice, Health Canada division 5, MUHC Standard Operation Procedures, etc., Prepare and lead institutional, sponsor and health agencies monitoring and audits. Website of the organization Bachelor's Degree Field of Study: Health sciences, Ethics, Public Health, Research on human, pharmacology Other education considered an asset for this position: Certification in Ethics, GCP, HCD5, other research program, clinical trials certification Work Experience: 2 years in clinical trials field An advanced knowledge of oral and written French.

An advanced knowledge of oral and written English is required,



as the position requires regular and complex contact with researchers or international students who are exclusively proficient in English. The position also requires complex writing or in-depth analysis of documents in English related to a research project. Capacity to work autonomously or with teams with minimum supervision, Proficiency in Microsoft Office (Word, Excel, Teams, Outlook) and Adobe.

Experience with NAGANO and ethics submission an asset. Temporary, full time (35-hour workweek) Work Shift: Monday to Friday 8:30am to 4:30pm Work Site: Glen Site, 1001 Decarie Blvd. 4-week vacation, 5th week after 5 years, ~ Bank of 12 paid days (personal days and days for sickness or family obligations), ~13 paid statutory holidays, ~ Telemedicine, ~ RREGOP (defined benefit government pension plan), ~ Training and professional development opportunities, ~ Child Care Centres, ~ Corporate Discounts (OPUS + Perkopolis), ~ Competitive monthly parking rate, ~ Employee Assistance Program, ~ THIS IS NOT A HOSPITAL POSITION.

The Research

Institute of the McGill University Health Centre hires on the basis of merit and is strongly committed to equity, diversity and inclusion within its community. We welcome applications from all qualified candidates who self-identify as members of racialized groups/visible minorities, women, Indigenous persons, persons with disabilities, ethnic minorities, and 2SLGBTQIA+ persons. We also welcome candidates with the skills and knowledge to productively engage with diverse communities.

Persons with disabilities who anticipate needing accommodations for any part of the application process may confidentially contact, research.

📌 Clinical Research Coordinator - Ethics & Regulatory Affairs (Montreal)
🏢 RI-MUHC | Research Institute of the MUHC | #rimuhc
📍 Montreal

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