The Quality and Regulatory Advisor will provide coordination & oversight of all aspects related to regulatory requirements for the Clinical Trials Unit to assure integrity of the work with respect to accuracy, accountability and safety. This position will ensure planning, coordination, control and continuous improvement of processes established to control the quality of clinical trials conducted at CCI. This job is responsible to compile, organize and submit to regulatory agencies documentation required for clinical trial applications as required. They represent the CTU in critical process & risk identification and evaluation of trials as part of the Unit Quality Management system. Along with investigators and CTU management they will determine systemic safeguards to reduce risk to an acceptable, proportional level. This role serves as an advisor and support to staff and management of the Clinical Trial Unit. The position will be involved in training new staff and updated training as required. The position will work with pharmaceutical monitors/representatives and facilitate regulatory inspections and sponsor audits. The advisor will assist other departments within the CCI that are involved with clinical trials on regulatory responsibilities and provide education as required.
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 and 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.
Department: CCI CTU Indirect Cost
Primary Location: Cross Cancer Institute
Negotiable Location: Within Edmonton Zone
Employee Class: Regular Full Time
Posting End Date: 12-AUG-2020
Date Available: 28-SEP-2020
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. Quality System/Quality Assurance background or training. Familiar with Quality Management Systems, and strong process improvement skills. Experience with regulatory inspections and audit responses (CAPA/root cause analysis.) 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 therapeutic areas/tumor groups as it relates to regulatory compliance, and protocol administration and management.
Additional Required Qualifications:
Clinical Trial Site Monitoring experience. Oncology Clinical Trial experience. Well-developed interpersonal oral and written communication skills. Computer literate in MS Word, Excel, PowerPoint.
SOCRA or ACRP Certification. Experience with regulatory submission preparation (CTA) to Health Canada directorates (TPD, NNHPD, BGTD). Experience with protocol development. Working knowledge of AHS research environment.