Clinical Research Coordinator – Ethics & Regulatory Affairs

RI-MUHC | Research Institute of the MUHC | #rimuhc; Montreal (administrative region); On-site; CAD 60,000 - 80,000; Full time

Benefits offered by this job

Vacation weeks

Paid personal days

13 paid holidays

Insurance plan

Telemedicine

Pension plan

Training & development

Child care support

Employee discounts

Parking

EAP

Recognition program

Flexible work options

Job summary

The Research Institute of the MUHC (RI-MUHC) in Montreal invites applications for a Clinical Research Coordinator – Ethics & Regulatory Affairs. The role focuses on ethics submissions, regulatory affairs, and support for PI-initiated and industry trials in chronic viral illnesses.

You will liaise with researchers, sites, and sponsors to ensure compliance and timely approvals. Ideal candidates hold a health sciences degree, strong French and English skills, and experience with regulatory

Qualifications

• Bachelor's Degree in Health sciences, Ethics, Public Health, or related field.
• At least 2 years of experience in clinical trials or research settings.
• Experience with ethics submission processes and regulatory documentation is an asset.

Responsibilities

• Lead ethics submission preparation and MUHC REB approvals.
• Maintain regulatory documents and ISF; manage training logs and DOA records.
• Coordinate site visits, amendments, and regulatory submissions with stakeholders.
• Support investigators and staff on regulatory compliance and GCP requirements.

Skills

French language

English language

Professionalism

Communication skills

Education

Bachelor's Degree

2 years clinical trials experience

Tools

NAGANO

Microsoft Office

Adobe

Job description

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

• 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

• 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.

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, [e-mail]