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Quality Assurance and Regulatory Compliance Lead

Employer
Global Academy Jobs
Location
Canada
Closing date
Oct 10, 2016

Job Details

This position offers a comprehensive benefits package which can be viewed at: www.hrs.ualberta.ca.

The Canadian VIGOUR Centre (CVC) is an academic research organization comprised of internationally recognized thought leaders in cardiovascular medicine and clinical investigation. The CVC specializes in managing clinical research projects of cardiovascular therapies from study design through to manuscript publication.

 The CVC involves researchers from the University of Alberta, as well as specialists from across the country and internationally (CVC has a network of over 400 Principal Investigators across Canada). Clinical research projects are funded through research grants and contracts from industry and external peer-reviewed agencies and foundations. The Canadian VIGOUR Centre (CVC) is affiliated with a global collaboration of coordinating centres, academic cardiovascular investigators, and thought leaders.

The Quality Assurance and Regulatory Compliance Lead is responsible for a variety of activities associated with quality assurance and regulatory compliance for clinical research projects at the Canadian VIGOUR Centre.  

Duties

  • Conducts internal audits of clinical research projects or associated projects within CVC to assess compliance with SOPs, GCP and regulations; prepares audit reports based on SOPs and assists the organization and team(s) in the development of corrective action plans; monitors and supports subsequent implementation and completion of corrective actions
  • Identifies trends and inconsistencies within or across multiple projects and provides support on development of resolutions which align with the regulations and SOPs and/or ensures SOPs are updated to align with changes
  • Conducts external audits of subcontractors for the purpose of vendor qualification, including due diligence review, vendor site audits, and periodic re-evaluations; prepares audit reports based on SOPs and reviews and approves corrective action request plans submitted by the subcontractor
  • In collaboration with the CVC Supervisor and/or Assistant Director(s) and appropriate clinical research projects study team(s), represents the CVC during internal audits conducted by external organizations including sponsors and regulatory authorities; prepares to anticipate potential issues arising from audits and prepare appropriate audit responses; tracks and maintains audit files electronically within CVC systems
  • Supports site audits and inspections conducted by Health Canada, FDA, and Sponsors both on site and remotely as required; works with the CVC Clinical trial/clinical research project study team, sponsors, and sites to respond appropriately to questions throughout the audit and the identified observations; keeps confidential, tracks and maintains electronic documentation of all inspections
  • Conducts quality oversight visits of monitors for all CVC monitored projects to assess compliance with SOPs, GCP and regulations
  • Develops and updates a CVC quality assurance plan, training plan, and relevant risk assessment plans with review and approval by appropriate supervisor and/or Assistant Director(s)
  • Develops, reviews, updates and approves CVC SOPs on a routine and as-needed basis to reflect changes/updates to clinical trial/clinical research project regulations/guidelines and internal practice
  • Provides consultation and training to CVC personnel on relevant internal and external SOPs being utilized and ensures that all training is maintained, documented and tracked
  • Provides training and education to staff on relevant ICH/GCP, Health Canada and FDA Regulations which are pertinent to their roles and responsibilities; provides guidance and support to CVC staff regarding GCP, Health Canada, and SOP compliance issues
  • Maintains current and up to date knowledge of ICH/GCP, Health Canada Regulations, FDA Regulations, NIH, and TCPS2
  • Maintains current knowledge of and develops and updates internal best practices associated with electronic filing and storage in line with GCP and regulatory requirements; collaborates with internal clinical trial/clinical research project teams and supervisor to ensure processes align with project specific requirements
  • Prepares, tracks and follows up on Clinical Trial Applications (CTA) for submission to Health Canada on investigator-nitiated and other relevant studies


Qualifications

  • Minimum of an undergraduate degree in a scientific or health related discipline or equivalent
  • 5 years of experience in a quality assurance or related area within pharmaceutical, CRO/ARO, or other clinical research environment
  • In-depth knowledge of Health Canada regulations, FDA regulations and ICH/GCP; experience with TCPS and NIH is an asset
  • Well-developed interpersonal communication (written and verbal) skills
  • Excellent problem-solving skills
  • Strong attention to detail
  • Proficient using MS Word, MS Excel, MS PowerPoint, Gmail, SharePoint, Clinical Trial Management System (CTMS)
  • English as primary language required
  • Bilingual in English and French is an asset

Company

Global Academy Jobs works with over 250 universities worldwide to promote academic mobility and international research collaboration. Global problems need international solutions. Our jobs board and emails reach the academics and researchers who can help.

"The globalisation of higher education continues apace, driving in turn the ongoing development of the global knowledge economy, striving for solutions to the world’s problems and educating a next generation of leaders and contributors."

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