Clinical Research Coordinator - Regulatory Affairs (Research Institute)
Clinical Research Coordinator - Regulatory Affairs (Research Institute)
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Job Description
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 Qubec - Sant (FRQS).
Position summary
Under the direct supervision of the Manager of Research Centre for Innovative Medicine (CIM) the Clinical Research Coordinator Regulatory is responsible for supporting the successful conduct of clinical research studies in the Centre for Innovative Medicine.
General Duties
Review and revise sponsors 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 manager.
Website of the organization
Required Skills
Knowledge of clinical research hospital/clinical setting is preferred
Minimum 2 year of experience in ethics and/or regulatory submissions is a definite asset
Experience working with the Nagano platform and/or Clinical Trial Management System (CTMS) is an asset
Knowledge of international federal and provincial laws and regulations governing clinical research (ICH-GCP) is an asset
Able to multi-task and prioritize workload
Organized
Bilingual: French and English spoken and written
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.
Required Experience:
IC
Employment Type
Unclear
