The Investigator Initiated Trials Quality and Regulatory Advisor will provide coordination, project management and oversight of all aspects related to regulatory requirements for Investigator Initiated Trials (IITs) (and other trials as needed) to assure the integrity of the trial with respect to logistics, accuracy, accountability and safety. This position will play an integral role in developing and implementing a quality assurance/regulatory strategy as the Investigator Initiated Trial program continues to expand in the Clinical Research Unit. This position will ensure planning, coordination and continuous improvement of processes and methods established to control the quality of IIT studies being conducted at Tom Baker Cancer Centre (TBCC) and ensure timelines are set and adhered to. This position is crucial to ensuring the success of the TBCC Investigator Initiated Trial Program.
Ensures that investigators and staff adhere to FDA, ICH-GCP, Health Canada regulations. Provide guidance and navigation for investigators through regulatory processes. Prepare clinical trial applications, amendments and notifications for Investigator Initiated trials for investigators that will be submitted to Health Canada. Reviews protocol requirements with CRU personnel and assists in feasibility analyses to ensure successful completion of the study. Provides support and guidance on regulatory issues to the IIT Project Manager within the CRU. Mitigate risks using appropriate risk reduction activities (protocol design, implementation, monitoring plans, systemic safeguards) to reduce risk to acceptable level which is proportionate to significance of risk. Identifies and assesses regulatory issues, applies knowledge of best practices and provides solutions to resolve these issues to the Manager and/or Director of the Clinical Research Unit. Generates and/or facilitates implementation of ideas for increasing efficiency productivity and quality of data. Assists investigators in writing investigator initiated protocols ensuring that regulatory and compliance requirements are met. Identify opportunities for innovation and quality improvement in current practices within the CRU and collaboration Departments. Maintains and shares knowledge of current Health Canada regulations and emerging topics, anticipate impact on current and future projects. Manages IIT site inspections and provides support and guidance to Investigator and study staff. Liaise with Health Canada Therapeutic Products Directorate (TPD), Biologics and Genetics Therapies Directorate (BGTD) and the Natural and Non-prescription Health Products Directorate (NNHPD) on existing and future protocols, as required.
Department: ACB TOM BKR CC Research Admin
Primary Location: Tom Baker Cancer Centre
Negotiable Location: Within Calgary Zone
Employee Class: Regular Full Time
Posting End Date: 17-JUL-2019
Date Available: 29-JUL-2019
Hours per Shift: 7.75
Length of Shift in weeks: 2
Shifts per cycle: 10
Shift Pattern: Days
Days Off: Saturday/Sunday
Minimum Salary: $28.20
Maximum Salary: $48.45
Vehicle Requirement: N/A
Undergraduate degree in a related field. Minimum of 5 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. Experience with regulatory submission preparation (CTA) to Health Canada Directorates (TPD, NNHPD, BGTD). Experience with protocol development. Working knowledge of AHS research environment. Oncology clinical trial experience. Well-developed interpersonal oral and written communication skills.
Additional Required Qualifications:
ACRP or SOCRA certification preferred.