Website Providence Health Care
Established for 15 years the St Paul’s Hospital Hematology/Oncology research group specializes in investigator driven and industry sponsored clinical trials in blood disorders and blood cancers.
Job Summary:
At St. Paul’s Hospital in Hematology/Oncology Research the primary functions of a Research Coordinator is to coordinate all aspects of clinical trials, as outlined below. The Research Coordinator reports to the Research Manager and Investigators in Hematology/Oncology Research. 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.
Work Performed
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 Contract Research Organizations (CRO’s).
• 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 PowerPoint.
• Availability for some after-hours and week-end work when required
Education and Experience
• 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
