Ensures that investigators and staff adhere to FDA, ICH-GCP, Health Canada regulations. Prepares clinical trial applications, amendments and notifications for investigators that will be submitted to Health Canada (TPD, BGTD, NNHPD). Reviews protocol requirements with CTU personnel, IIT team, and assists in feasibility analyses. Provides support and guidance on regulatory issues to management & staff of the CTU, work to liaise with other partner institutions (TBCC, UofA). Along with investigators and management determine critical processes and perform risk identification and evaluations. Mitigate risks using appropriate risk reduction activities (protocol design, implementation, monitoring plans, systemic safeguards) to reduce risk to acceptable level. Identifies and assesses regulatory issues, applies knowledge of best practices and provides solutions to the Manager and/or Director of the Clinical Trial Unit, and other departments. Generates and/or facilitates implementation of ideas for increasing efficiency, productivity and quality improvement. Maintains and shares knowledge of current Health Canada regulations and emerging topics anticipating impact on current and future projects. Conducts monitoring of Investigator Initiated trials, and others as required to assure accuracy, accountability, and documentation of data (may include off site visits). Effectively communicates monitoring results, deviations, detected deficiencies and corrective action taken or planned, to investigators and clinical trial staff. QMS development. Interaction/Consultation with other Agencies, AHS Departments and CCI staff; committee work as required. Manages site inspections and provides support and guidance to Investigator and Study Staff.
Undergraduate degree in a related field. SOCRA or ACRP Certification. Minimum of five years clinical trial experience including site coordination of clinical trials. In-depth knowledge of clinical trial and drug development processes including ICH-GCP, FDA and Health Canada regulatory requirements. Demonstrated ability to manage multiple trials and tumor groups as it relates to regulatory compliance and protocol administration and management. Clinical Trial Site Monitoring experience. Oncology Clinical Trial experience.Additional Required Qualifications:
Well-developed interpersonal oral and written communication skills. Computer literate in MS Word, Excel, PowerPoint.Preferred Qualifications:
Experience with regulatory submission preparation (CTA) to Health Canada directorates (TPD, NNHPD, BGTD). Experience with protocol development. Working knowledge of AHS research environment.