Clinical Research Coordinator - CAR-T Therapy

About the Organization

The Research Institute of the McGill University Health Centre (RI-MUHC) is a globally recognized biomedical and hospital research facility located in Montreal, Quebec. Serving as the research branch of the McGill University Health Centre and affiliated with McGill University's Faculty of Medicine, it is partly funded by Fonds de recherche du Québec - Santé (FRQS). The RI-MUHC focuses on innovative biomedical science and patient-centered medical research.

Position Overview

The Clinical Research Coordinator (CRC) focusing on CAR-T therapy will play a crucial role in managing complex clinical trials related to cellular therapy, particularly CAR-T studies, in the Centre for Innovative Medicine. Reporting directly to the program manager, Dr. Michael Sebag, the CRC supports the Principal Investigator and clinical research teams to ensure trials comply with federal regulations, Good Clinical Practice principles, institutional policies, and sponsor obligations. Experience in oncology and cellular therapy clinical trials in regulated environments is preferred.

Key Responsibilities

• Develop Standard Operating Procedures (SOPs) tailored to CAR-T projects that integrate local protocols and coordinate interdepartmental requirements.
• Prepare and submit necessary regulatory documentation to sponsors and health authorities as required.
• Support audit and inspection preparedness and response activities.
• Organize bi-weekly meetings with key MUHC stakeholders, Qualified Investigators, and study teams.
• Coordinate scheduling of procedures such as leukapheresis, lymphodepletion, CAR-T infusion, and extended follow-up in collaboration with clinical research coordinators and investigators.
• Maintain accurate source documentation and coordinate with the clinical research team to ensure data integrity.
• Act as the main liaison among investigators, sponsors, Contract Research Organizations (CROs), cell processing laboratories, Hema Québec, MUHC departments, and clinical teams.
• Coordinate logistics with pharmacy, apheresis units, inpatient/outpatient units, and laboratory services.
• Participate in monitoring visits, site initiation visits, and sponsor meetings as needed.
• Support multidisciplinary operations of the CAR-T program.
• Communicate urgent and significant information promptly to research staff, investigators, managers, and clinical personnel.
• Collaborate both internally and externally to gather information and ensure all necessary clinical tests and procedures are fulfilled.
• Manage correspondence including emails and follow-up letters from sponsors and monitors.
• Engage in study-specific and institutional training, including site initiation, Good Clinical Practice, regulatory compliance, SOPs, and use of clinical trial management systems.

Performance Expectations

• Ensure timely distribution of critical information.
• Maintain rigorous organizational and scheduling standards.
• Provide prompt reporting of data and issues to management.
• Ensure internal departments are well-informed and prepared to support related research activities.

Qualifications and Experience

• Bachelor’s degree in nursing, life sciences, public health, or a related discipline.
• Minimum of two years’ experience within a hospital or clinical research setting.
• Proficiency in French is mandatory.
• Advanced oral and written English skills are essential due to frequent interactions with English-speaking patients, researchers, or international collaborators.

Additional Details

• Employment Status: Temporary, part-time position at 15 hours per week.
• Work Shift: Flexible schedule arranged in coordination with study physicians, including availability for overtime as needed.
• Work Location: Glen Site, 1001 Decarie Blvd., Montreal.
• Compensation will be aligned with candidate’s education and experience.

Employee Benefits

• Six days of paid sick leave annually, which includes up to three personal days.
• Vacation entitlement calculated proportionally based on salary percentage.
• Modular group insurance plans inclusive of gender affirmation coverage.
• Participation in the RREGOP defined benefit government pension plan.
• Additional pay equal to 5.3% of gross earnings in lieu of statutory holidays.

Equal Opportunity and Diversity

The RI-MUHC is committed to equity, diversity, and inclusion, welcoming applications from all qualified individuals including members of racialized groups, women, Indigenous people, persons with disabilities, ethnic minorities, and 2SLGBTQIA+ individuals. Candidates with experience engaging diverse communities are especially encouraged to apply. Accommodations are available throughout the recruitment process upon request.