Clinical Research Coordinator

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: Department of Obstetrics and Gynecology

The Endometriosis Research Program at the Research Institute of the McGill University Health Centre conducts patient-oriented clinical and epidemiological research aimed at improving the diagnosis, treatment and lived experience of people with endometriosis. Reporting to Drs. Andrew Zakhari, Dong Bach Nguyen and Basile Tessier-Cloutier, the clinician-scientists who lead the program, the incumbent is responsible for the scientific and operational management of the program’s portfolio of studies, from ethics submission and study registration through recruitment, data collection and analysis support, to publication and knowledge translation. The incumbent is expected to work with a high degree of autonomy: setting priorities, anticipating deadlines and advancing projects independently rather than waiting for direction. The role combines regulatory and operational coordination with academic support (grant and manuscript preparation, communications, promotion dossiers) and genuine scientific participation in the design and interpretation of studies. This is a central position on a small, collaborative team, and the incumbent will contribute to program planning and scientific discussion, not solely to execution.

General Duties

Regulatory affairs and research quality

• Prepare, submit and maintain research ethics board (REB) applications, including initial submissions, amendments, annual renewals and study closures, for all projects in the program,
• Ensure that all studies are conducted in accordance with ICH-GCP, TCPS 2, applicable Québec privacy legislation and RI-MUHC standard operating procedures,
• Register studies on public registries (ClinicalTrials.gov, PROSPERO, OSF) and keep registration records current,
• Maintain investigator study files, delegation logs and training records, prepare the team for audits, monitoring visits and inspections,
• Draft and maintain study protocols, standard operating procedures, consent forms, case report forms and data management plans.

Study conduct and participant management

• Identify, screen and recruit eligible participants, obtain and document informed consent,
• Schedule and coordinate study visits and serve as the primary point of contact for participants,
• Distribute and track follow-up questionnaires, ensure their completion, and implement retention strategies to minimize loss to follow-up,
• Coordinate biological sample collection, labelling, processing and shipping where applicable, and liaise with the biobank,
• Process participant compensation and reimbursements, document adverse events and protocol deviations and report them as required.

GREAT Biobank operations

• Coordinate participant enrolment and consent under the GREAT biobank protocol and ensure that consent scope (data linkage, future use, sharing with partners) is documented for every participant,
• Coordinate intra-operative tissue, blood and peritoneal fluid collection with the operating room team and the Department of Pathology, ensure chain of custody, labelling, processing and storage of samples according to standard operating procedures,
• Maintain the sample inventory, freezer and laboratory information management system (LIMS) records, quality-control logs and annual reporting to the REB and the biobank,
• Link clinical, radiologic, surgical (lesion mapping) and pathology data to banked samples in the study database,
• Manage sample and data access requests, including material transfer and data-sharing agreements with collaborators and industry partners.

Data management and analysis support

• Design and build study databases (e.g. LabKey), including data dictionaries, validation rules and access controls,
• Organize, clean, de-identify and format datasets, maintain version control and supporting documentation,
• Produce descriptive summaries