Quality Assurance - Calgary, Canada - The University of Calgary

The University of Calgary

Verified Company

Calgary, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Position Overview
Reporting to the Director, Clinical, Health Services and Population Health Research.

Position Description

Summary of Key Responsibilities (job functions include but are not limited to):
Internal Audit Visits

Conduct internal audits of principal investigator initiated clinical research projects to assess compliance with the protocol, SOPs, GCP and regulations; prepares audit reports based on SOPs and assists the University and research team(s) in the development of corrective action plans; monitors and supports subsequent implementation and completion of corrective actions to ensure compliance
Monitor and report any trends and inconsistencies identified through the internal audits to leadership. Create a development plan for resolutions which align with the regulations and SOPs and/or ensures SOPs are updated to align with changes. This may include providing support, education, or guidance to study team
Prepare researchers conducting investigator initiated clinical trials for external regulatory inspections. Works with study team and sites to review study records for completeness and discuss expectations during the inspection
Acts as an expert in supporting and providing mentorship for site audits and inspections conducted by Health Canada and FDA as required; works with project study team and sites to respond appropriately to questions throughout the audit or inspection and the identified observations; maintains confidentiality, tracks and maintains electronic documentation of all inspections
Provide verbal and written feedback to researchers including summaries of overall trial functioning, detected deficiencies and corrective actions. Follow up/monitoring of sites until deficiencies are resolved to ensure compliance

Education and Training

Promote awareness of the regulations and guidelines governing clinical research to researchers, faculties, departments, and other interested parties
Act as an expert advisor for site questions and issues. Provide clinical guidance to investigators and study coordinators as needed
Promote awareness of N2Canada SOPs, providing guidance on implementation and training
Develop and lead educational initiatives with tools and templates for study teams that will ensure regulatory compliance when conducting clinical research
Provide ongoing training opportunities for research coordinators and other team members based on audit findings
Conduct presentations each year to the clinical research community on areas of interest, common findings from file reviews, revisions to the regulations

Monitoring Service Management

Manage the intake process for new studies interested in utilizing the monitoring service
Manage and provide oversight for the study monitors and assist with solving complex problems that may be identified during a monitoring visit
Maintain the tools, templates, and guidance documents for the monitoring service to ensure compliance with all international guidelines and regulations

Other Responsibilities

Serve as the Institutional contact for N2Canada, by disseminating information to the research teams
Participate as a member of the N2Canada Quality Committee

Qualifications / Requirements:

University degree (Master's level) with 57 years of progressively responsible experience in a related role, preferably in an academic or hospital environment
Experience in a management or supervisory role is an asset
Extensive experience in health research, particularly ethical and other legal and regulatory aspects
Knowledge of University research ethics policies and procedures
Good working knowledge of Alberta Health Services operating procedures
Documented experience conducting clinical trial audits and relevant training (e.g. Barnett 30Hour Clinical Research Auditing Certification Program.)
Exceptional interpersonal and communications skills, including the ability to exercise tact, diplomacy and exercise good judgment especially in situations of communicating difficult concepts and negotiating with others to adopt new processes to improve compliance
Exceptional organization and presentation skills and innovative thought in complex problemsolving
Proficient in and comfortable with information technology including online systems, and electronic software programs such as Microsoft word and Excel
Familiar with university core business systems (IRISS, PeopleSoft, Enterprise Reporting tools)
Maintains a current Clinical Research Certification (ACRP or SoCRA)

Application Deadline:
June 23, 2023

Additional Information
This position is classified in the
Professional Career Band, Level 4
of the Management and Professional Staff Career Framework.

Management and Professional Staff (MaPS) Positions are currently under review as part of the Alberta Labour Relations Board exclusion review process.

Visit the HR website for more information.

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