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The Research Coordinator must have a good working knowledge of the principles and procedures of Clinical Research. This includes ensuring study conduct with adherence to ICHGCP, FDA and Health Canada guidelines. This position is a 1-year full time contract (7.5 hours per day and a 3-month probationary period) renewed on an annual basis.

The Research Coordinator’s major responsibilities include:

• Review and self-training on active study protocols and procedures, Informed Consent Forms and site SOPs
• Recruitment, obtaining consent, screening and enrollment of study subjects
• Protection of subjects' rights and confidentiality
• Data collection, entry, analysis and monitoring
• Preparation of source worksheets, subject procedure bookings, lab kits and room booking for study visits
• Occasionally, collection of biological samples (training will be provided)
• Shipping of study materials and bio-specimens, as required
• Preparation and timely submission of adverse event and serious adverse event reports
• Investigational product accountability, receiving and dispensing
• Ongoing support of and contact with subjects for study visit bookings, follow-ups and promotion of subject retention
• Communication with and education of other health professionals, study subjects and their families regarding clinical trials
• Acting as a key liaison with the Research Manager, Principal Investigator (PI), sponsors and

• Completion of Good Clinical Practice (GCP) certification, Transportation of Dangerous Goods (TDG) certification and shipping study samples
• Audit preparation and REB submissions
• Maintaining safety reports, regulatory and other study-related documents

• Meeting with study sponsors or their representatives for site-selection, site-initiation, monitoring and closeout visits

The Research Coordinator should also possess:

• Effective interpersonal, oral and written communication, organization and problem-solving skills
• Ability to work independently and within a team environment
• Computer proficiency including use of Word, Excel and Power Point
• Availability for some after-hours and week-end work when required

• Undergraduate degree in a relevant discipline
• Minimum of one-year research experience. Experience in coordinating industry-sponsored clinical trials is preferred
• Clinical trials education (GCP, Tri-Council Policy and Part C, Division 5 of the Food and Health Regulations) an asset

Benefits:

• Dental care
• Paid time off
• Vision care

Schedule:

• Day shift
• Monday to Friday

Work Location: In person