Coordinator, ethic and regulatory affairs for clinical research

Founded in 1967, the Montreal Clinical Research Institute (IRCM) is a non-profit organization dedicated to basic and clinical biomedical research in a wide variety of fields, as well as the training of the next generation of scientists in an innovative technological environment. 

The IRCM is currently looking to recruit an ethic and regulatory affairs coordinator for clinical research.

Summary of responsibilities

Under the supervision of the Vice-President, Clinical and Clinical Research, and the Chair of the Research Ethics Board (REB), the coordinator acts as a resource person for researchers and their teams in all matters related to clinical research compliance, and coordinates all REB activities. He/she participates in the elaboration and deployment of the strategic plan for the development of clinical research.

Main tasks and responsibilities: 

Activities related to the coordination of regulatory affairs
Responsible for ensuring the implementation of operational processes in clinical research. Primary role as a resource person in regulatory affairs for research teams.
•    Writes, implements and updates standard operating procedures (SOP)
•    Monitors continuing education programs in clinical research
•    Manages requests for access to the patients’ medical records for research purposes
•    Manages the archiving, training and registration platforms for clinical studies
•    Assumes the role of liaison with health network institutions and clinical research associations/regulatory bodies

Activities related to REB coordination
Responsible for ensuring the coordination of REB activities. Primary liaison and training role between the REB and the research teams. 
•    Responsible, with the REB Chair, for the review process and ongoing monitoring of research projects submitted to the REB
•    Supervises the research teams in the preparation and submission of research projects to the REB
•    Manages the Nagano platform (content, access, training, etc.)
•    Coordinates REB meetings and attends as a permanent guest
•    Writes and updates REB documents according to the applicable regulations (SOP, information and consent forms, etc.)
•    Participates in the preparation of activity reports, the recruitment of new REB members and contributes to special projects
•    Oversees the billing of the private company for the evaluation, authorization and monitoring of research projects

Activities related to the management committee of the clinic and clinical research
Carries out mandates for the development and improvement of clinical research processes within the committee. 
•    Contributes to the implementation of the actions required for the deployment of the strategic plan
•    As a member of the management committee, ensures the follow-up of files according to deadlines
•    Participates in the collection of information for the follow-up of performance indicators and for the various reports and presentations 
•    Participates in the drafting of communiqués and directives 

Required qualifications:
•    Bachelor's or master’s (an asset) degree in a relevant discipline (science, bioethics, etc.)
•    Minimum of three (3) to five (5) years experience in clinical research or a similar position
•    Functional bilingualism (French, English)

Knowledge and abilities:
•    Very good knowledge of Canadian and international ethical and regulatory standards applicable to clinical research
•    Knowledge of standard software. Previous experience with the Nagano software would be considered an important asset. 
•    Strong organizational, prioritization and problem-solving skills 
•    Strong communication skills, both verbal and written
•    Strong autonomy
•    Ability to work in a team, good interpersonal skills, thoroughness in the execution of tasks and strong attention to details.

Conditions of employment:
•    Full-time position (35h/week) during the day (Monday to Friday) 
•    Flexible hours and teleworking possible
•    Start date as soon as possible
•    Benefits in accordance with IRCM policies:
-    Contribution to the Régime de retraite des employés du gouvernement et des organismes publics (RREGOP)
-    20 days of vacation
-    13 paid statutory holidays and 10 days of sick leave per year
-    Life, health and salary insurance plans
-    Employee Assistance Program

How to apply:
Send your resume and cover letter specifying the Competition - Coordinator, ethic and regulatory affairs for clinical research to the following email address: RecruteRH@ircm.qc.ca
We thank all applicants for their interest, however only those selected for an interview will be contacted. Visit our website: http://www.ircm.qc.ca

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