Clinical Research Project Manager - Temporary Part-time Occasional (Research Institute)
Clinical Research Project Manager - Temporary Part-time Occasional (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 supervision of the Manager Pediatric & Adult Research at the Centre for Innovative Medicine (CIM) as well as following established governmental guidelines and regulations the incumbent is responsible for the management of a multicenter clinical research study.
General Duties
Manages site feasibility questionnaire and qualification visits
Ensures start-up activities including site initiation
Customizes study material for Canada
Prepares and provide site training
Primary liaison to clients ensuring questions is answered and issues are resolved
Primary liaison to biostatistician to ensure analysis of research questions are appropriately addressed
Oversees project timelines and patient accrual
Prepares and ships study materials to sites
Follows-up on recruitment activities according to study timelines
Manages other study activities such as monitoring visits data management and statistics deliverables
Follows-up on regulatory activities
Prepares newsletters for sites
Manages payment to sites
Manages the study budget
Conducts and coordinates the meeting with sponsor and other stakeholders
Responsible for follow-up meetings with sponsor
Provides regular status report to sponsor
Offers support to sites
Other duties as assigned by the supervisor.
Required Skills
Bilingual (Excellent verbal and written communication skills in French and English)
Working knowledge of project and budget management
Clinical research accreditation is preferred
Excellent organizational skills
Ability to manage multiple priorities and prioritizing for time-sensitive issues
Excellent knowledge of international federal and provincial laws and regulations governing clinical research (ICH-GCP)
Self-directed and organized. Able to work both independently and as part of a team
Excellent interpersonal skills
Basic knowledge of biostatistics and Data management is preferred
Proficient with technology systems (EDC MS Excel Power Point etc.).
Required Experience:
IC
Employment Type
Unclear
