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: Oncology, phase 1, Complex care
Under the direct supervision of the program manager - Dr Michael Sebag, the Clinical Research Coordinator (CRC) – CAR-T is responsible for supporting the successful conduct of clinical research studies in the Centre for Innovative Medicine.
The Clinical Research Coordinator (CRC) – CAR-T Therapy is responsible for the coordination and management of complex cellular therapy clinical trials, with a focus on Chimeric Antigen Receptor T-cell (CAR-T) studies. This role supports the Principal Investigator (PI) and clinical research team in ensuring trials are conducted in compliance with federal regulations, GCP guidelines, institutional policies, and sponsor requirements.
The ideal candidate has experience in oncology and/or cellular therapy trials and thrives in a fast-paced, highly regulated clinical research environment.
General Duties
- Create Standard Operating Procedures (SOPs) for CAR-T projects that incorporate local practices and interdepartmental requirements,
- Prepare and submit regulatory documents to sponsors, and regulatory agencies as required ,
- Assist with audit and inspection preparation and support as needed Organizes bi-weekly meetings with the key MUHC stakeholders and Qualified Investigator and study team,
- Coordinate with the Clinical research Coordinator and QI regarding the contacts and scheduling requirements for procedures, leukapheresis scheduling, lymphodepletion, CAR-T infusion, and long-term follow-up,
- Coordinate with the clinical research coordinator to create and maintain accurate source documentation,
- Serve as primary liaison between investigators, sponsors, CROs, cell processing labs, Hema Québec, MUHC departments and clinical teams,
- Coordinate schedule with pharmacy, apheresis, inpatient/outpatient units, and laboratory services,
- Participate in monitoring visits, site initiation visit, and sponsor meetings as required ,
- Support multidisciplinary CAR-T program operations ,
- Relays immediately important information to the Research Team, Investigators, Managers, Supervisors, Clinical Research Coordinators, Research Nurses and other clinical research personnel, i.e., pharmacy, contracts office, REB, others,
- Collaborates with external customers and internally with the entire medical care team to obtain information and data, i.e., Pharmacy, and other clinical hospital providers (e.g. ensure all required tests),
- Answer emails and follow-up letters from sponsor/monitors,
- Participates and/or performs study specific or site materials trainings, may include self-training and training other study personnel. This includes but is not limited to, site initiation visits (SIVs), prequalification visits, Good Clinical Practice (GCP), Health Canada (HC) Division 5, SOPs (Standard of procedures), and other applicable trainings, supplemental trainings, workshops, readings, Clinical Trial Management System (CTMS), Nagano, and other as applicable.
Standards of performance:
- Ensure important information is distributed quickly,
- Maintains a high level of organization and scheduling ,
- Data, information and issues are collected and reported to Manager within a timely fashion,
- Internal departments are aware of and have documentation to perform related research tasks, i.e., pathology, lab.
Website of the organization
https://rimuhc.ca/en
Education / Experience
Education: Bachelor's Degree
Field of Study: nursing, life sciences, public health, or related field required
Work Experience: Minimum 2 years experience in a hospital/clinical setting
Required Skills
- Knowledge of French is required.
- An advanced knowledge of oral and written English is required, as the position requires regular and complex contact with patients, researchers or international students who are exclusively proficient in English.
Additional information
Status: Temporary, part-time: 15h per workweek
Pay Scale: Commensurate with education and experience
Work Shift: Other or part-time
Other: To be arranged with the study doctors. Flexibility and overtime required when needed
Work Site: Glen Site, 1001 Decarie Blvd.
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If you wish to include a cover letter, please attach it with your resume in one document. ***
Why work with us?
- 6 days of paid sick leave per year, which includes a maximum of 3 personal day,
- Vacation calculated on a pro-rata basis based on a percentage of your salary,
- Modular group insurance plan (including gender affirmation coverage),
- RREGOP government pension plan (defined benefit plan),
- 5.3% of your gross earnings will be added to your paycheque in lieu of statutory holidays.
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, [email protected]
