Clinical Research Coordinator - Regulatory Affairs (CIM)

RI-MUHC | Research Institute of the MUHC | #rimuhc; Montreal; On-site; CAD 46,000 - 84,000; Full time

Benefits offered by this job

4 weeks vacation

Paid personal days

13 statutory holidays

Pension plan

Telemedicine

Professional development

Parking

Employee assistance

Job summary

RI-MUHC in Montreal is seeking a Clinical Research Submissions Coordinator to support ethics and regulatory submissions and ensure compliance with standards. The role emphasizes collaboration with researchers and sponsors in a fast-paced environment.

You will work under the Centre for Innovative Medicine (CIM), reviewing consent forms, gathering documents, and submitting through Nagano while maintaining clear communication with Ethics, Contracts, Investigators, and Sponsors to optimize timelines.

Qualifications

• DEC in a science field.
• Experience in ethics or regulatory submissions is an asset.
• Knowledge of Nagano systems is an asset.

Responsibilities

• Review and revise sponsor’s informed consent forms to meet language standards.
• Coordinate with sponsors and study teams to assemble submission documents.
• Submit studies through Nagano to ethics and site reviews.
• Maintain ongoing communication with Ethics, Contracts, Investigators, and Sponsors during submission timelines.
• Optimize study review time.
• Primary point of contact for all stakeholders.
• Conduct other related tasks as assigned by supervisor.

Skills

French fluency

English fluency

Multi-tasking

Organized

Communication

Self-directed

Detail oriented

MS Office

Nagano knowledge

Regulatory submissions

Education

DEC in science field

Tools

Nagano systems

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

Under the supervision of the Manager, Clinical Research Administration Centre for Innovative Medicine (CIM), the incumbent is responsible for supporting the submission of clinical research studies to the Centre of Applied Ethics and other site specific assessment.

General Duties

• Review and revise sponsor’s informed consent forms so that it meets FRSQ standard approved language,
• Work with sponsors and study teams to obtain all documents required to start submissions,
• Submit studies through Nagano to reviewing committees (ethics and site specific reviews),
• Maintain on going communication with Ethics, Contracts, Investigators, and Sponsors during submission and renewal timelines to ensure that all needs are meet met,
• Optimize study review time,
• Primary point of contact for all stakeholders,
• Conduct other related tasks as assigned by supervisor.

Website of the organization

https://rimuhc.ca/en

Education / Experience

Education: Diploma of College Studies (DEC)

Field of study: Science

Work experience: Minimum 1 year of experience in ethics and/or regulatory submissions is a definite asset. Knowledge of clinical research.

Required Skills

• Advanced knowledge of oral and written French is required,
• 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,
• Able to multi-task and prioritize workload,
• Organized,
• Solid written and verbal communication skills,
• Able to work under minimal supervision,
• Quick learner, detail orientation, good adaptability and versatile,
• Excellent knowledge of computer skills, as well as Word, Excel and PowerPoint,
• Knowledge of Nagano systems an asset, and
• Self-directed, organized and sense of ethics.

Additional information

Status

Temporary full-time (6 months replacement)

Pay Scale

Commensurate with education & work experience. From $45,618.20 - $84,484.40 per year.

Work Shift

8:30 a.m. to 4:30p.m., Mondays to Fridays (35hours/week).

Work Site

Glen site (1001 Décarie Blvd)

THIS IS NOT A HOSPITAL POSITION.

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

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]