Clinical Research Coordinator – Ethics & Regulatory Affairs

Job summary

Coordinate ethics submissions and approvals, including initial applications, amendments, renewals, safety reports, and study close-out activities. Maintain regulatory files and training records, support trial start-up and monitoring, advise research staff on compliance requirements, and help prepare for institutional, sponsor, and health agency audits.

Job details

Do you want to work for a world-renowned research institute that pushes the boundaries of biomedical science and health research? Right here in Montreal! 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. Join us today and make a difference! Job Description 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). Position Summary 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 innovative 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. General Duties The position includes the following tasks, but are not limited to: 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.) stakeholders. Ethics activities Responsible for Ethics initial preparation and submission via NAGANO up to REB full approval and MUHC Authorization, Review start-up package for completeness, Prepare study ICFs as per the MUHC REB templates and obtain Sponsor approval, Primary point of contact for research ethics committees, Follow-up with Feasibility assessment, Organize Site Initiation Visit, Responsible for ongoing ethics activities submission and approval as amendments, notifications, annual renewal, close-out report, deviations, Serious Adverse Events, etc. 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, Responsible for Delegation of Authority logs. Additional tasks Organize Site Initiation Visits, and other trials trainings, Optimize study start-up and amendment approval timelines, Follow-up/meet with the CRA during/after monitoring visits, Assist with Investigator Initiated Study ethics and regulatory affairs, Act as a resource for staff with questions regarding the review process and requirements, MSSS multicentric submission with other sites in Quebec, Comply with Good Clinical Practice, Health Canada division 5, MUHC Standard Operation Procedures, etc., Respect different concurrent timelines, Prepare and lead institutional, sponsor and health agencies monitoring and audits. Website of the organization https://rimuhc.ca/en Education / Experience Education: 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 Required Skills This position requires 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. Must be professional, possess a high degree of efficiency and self-motivation, and have a strong work ethic and respect of confidentiality, Excellent communication and interpersonnel skills, Detail oriented, Demonstrates high organization and adaptability skills, High tolerance to work under pressure and with multiple short deadlines, 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. Additional information Status: Temporary, full time (35-hour workweek) Pay Scale: Commensurate with education and experience Work Shift: Monday to Friday 8:30am to 4:30pm Work Site: Glen Site, 1001 Decarie Blvd. ***If you wish to include a cover letter, please attach it with your resume in one document. *** Why work with us? 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, Modular group insurance plan (including gender affirmation coverage), 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, Recognition Program, Flex work options and much more! https://rimuhc.ca/careers To learn more about our benefits, please visit http://rimuhc.ca/en/compensation-and-benefits THIS IS NOT A HOSPITAL POSITION. Equal Opportunity Employment Program 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.talent@muhc.mcgill.ca

What you’ll do

Coordinate ethics submissions and approvals, including initial applications, amendments, renewals, safety reports, and study close-out activities. Maintain regulatory files and training records, support trial start-up and monitoring, advise research staff on compliance requirements, and help prepare for institutional, sponsor, and health agency audits.

Requirements

A bachelor's degree in health sciences, ethics, public health, human research, pharmacology, or a related field and at least two years of clinical trials experience are required. Advanced written and spoken French and English, strong organizational and communication skills, attention to detail, and proficiency with Microsoft Office and Adobe are required; ethics, GCP, Health Canada Division 5, and NAGANO experience are assets.

Benefits

• Four Weeks of Vacation
• Paid Personal, Sick, and Family Obligation Days
• Paid Statutory Holidays
• Group Insurance
• Telemedicine
• Defined Benefit Pension Plan
• Training and Professional Development
• Child Care Centres
• Corporate Discounts
• Employee Assistance Program
• Recognition Program
• Flexible Work Options

Listed skills

• Adobe · Preferred
• Organization · Preferred
• Communication · Preferred
• Microsoft Office · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Clinical Trial Coordination
• Research Ethics Submissions
• Regulatory Affairs
• Good Clinical Practice
• Health Canada Division 5
• Informed Consent Forms
• Investigator Site Files
• Regulatory Documentation
• Delegation of Authority Logs
• Clinical Trial Start-Up
• Amendment Management
• Monitoring and Audits
• Microsoft Office
• Adobe
• Organization
• Communication

Job areas

• Science & Research
• Healthcare
• Legal
• Administrative

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