Clinical Research Coordinator - Phase 1

Centre universitaire de santé McGill - Montréal, QC (30+ days ago)

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Job Description

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
Under the general supervision of Manager Phase 1, for the Centre for Innovative Medicine (CIM), the incumbent is responsible to conduct clinic interventions following protocols, procedures and internal SOPs.

General Duties
Obtains ethics committee approval of Phase 1 protocols and ensures ethical approvals throughout the study.

  • Maintenance of the Investigator Study File (ISF),
  • Recruits participants for studies, obtains informed consent, assesses subjects for protocol eligibility, and obtains medical history of the subject with consent,
  • Updates and completes forms for any adverse events or side effects, questionnaires and protocol-specific source documentation, Completes all follow-ups as per protocol requirements: visits and patient status,
  • Coordinates requisitions for requests and procedures related to protocols: consultation, pathology, diagnostic and analytical laboratories, etc.,
  • Coordinates all aspects of data collection and source documentation,
  • Completes all documents related to the study and respond to all queries,
  • Collaborates with the Study Monitor, Quality Assurance and Phase 1 Team,
  • Performs any other tasks identified by the Phase 1 Manager.
Website of the organization

Education / Experience
  • DEC in sciences or relevant experiences,
  • Minimum of two (2) years of clinical research experience,
  • Bilingual: English, French, spoken and written,
  • Strong written and verbal communication skills,
  • Ability to work with minimum supervision,
  • Independent, flexible, organized and ethical and compliant,
  • Knowledge of regulations, Health Canada, FDA, related to clinical research (ICH-GCP).
Additional information
Status : Full time
Pay Scale : Based on skills and experience.
Work Shift : 35 hours/ week
Work Site : Centre for innovative medicine, Phase 1 (GLEN Site)

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NOTE: The masculine gender has been used for brevity and includes the feminine gender.
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