Auditor, CTO Research Ethics Board Qualification Program For REBs Reviewing Health Related Observational Research Studies

Job type: Part-Time
Accepting BioReady™: Yes
Category: General Management, Operations and Administration
Education: Bachelor
Experience: 4-6 Years
Employer: Clinical Trials Ontario
Location: Toronto, ON
Posted: November 19, 2020
Closes: December 19, 2020

Position Description

Auditor, CTO Research Ethics Board Qualification Program 

For REBs Reviewing Health Related Observational Research Studies

(Part-Time, Casual)

 

Clinical Trials Ontario (CTO) is an independent, non-profit organization established in 2012 to support Ontario in achieving the vision of being a preferred location for global clinical trials while maintaining the highest ethical standards. A strategic focus for CTO is improving the speed and reducing the cost of conducting multi-centre clinical trials and health research studies by streamlining the research ethics review process.  To support the increased activity and interest related to observational research studies, the CTO REB qualification program is developing customized resources to accommodate REBs that review health-related observational research, but do not review clinical trials.  This Auditor position is targeted to individuals with experience and interests to the REB review of observational research.

 

The responsibilities of the Auditor will include developing qualification program materials and processes, preparing for and leading/conducting on-site reviews of Ontario REBs (who review health-related observational studies) when asked to do so by CTO, along with report drafting and other tasks. The site visits will involve travel within Ontario and may require overnight stay.  (Note: During the pandemic it is expected that all site reviews will be conducted remotely.)

 

The Auditor will have a strong understanding of the various regulations, policies and standards that govern the ethical conduct of health-related observational research in Ontario and be familiar with the application of these standards to research ethics reviews. The Auditor will work with a team that includes members of the REB community (peer reviewers) and will conduct the reviews in accordance with the CTO Qualification Manual and associated REB Qualification Checklist.

 

Specific responsibilities:

  • Provide expertise on research ethics review policies and applicable regulations and guidelines relevant to health-related observational studies;
  • Developing the CTO REB Qualification Manual and REB Qualification Checklist to be utilized for the review of Ontario REBs (who review health-related observational studies); Providing expertise and advice on the continued development and improvement of the CTO REB Qualification Manual, templates and processes;
  • Conducting review activities in accordance with the CTO REB Qualification Manual and REB Qualification Checklist (applicable to health-related observational studies) including scheduling and administration of site visits (identification of Qualification Team, visit coordination, communication and providing support to the Qualification Team);
  • Reviewing documentation submitted by institutions/REBs and preparing for on-site visits;
  • Participating in and/or leading on-site visits and providing advice and expertise to the REB under review regarding the qualification process and applicable regulations, policies and standards;
  • Drafting the Qualification report in accordance with the CTO template;
  • Reviewing Corrective Action Plans (CAP) submitted by institutions/REBs and providing a final decision regarding the qualification status of the REB; establish consistency amongst Qualifications; ensure all findings are consistent with the CTO REB Qualification Manual and have a basis in applicable regulations and seeking guidance from external bodies as appropriate;
  • Working with the CTO team and institutions/REBs to ensure the scheduling and conduct of CTO REB Qualification processes and annual reviews in a professional, timely and efficient manner;
  • Reviewing annual reporting forms and associated documents submitted by CTO Qualified REBs;

 

Essential Background and Skills:

  • Minimum undergraduate or college degree in a health sciences-related field;
  • Knowledge of REB operations and health-related observational research/study processes;
  • At least 5 years’ experience (combined) in either auditing, monitoring, or quality assurance for observational (non-medical) research/studies or administering/coordinating the operations of a REB;
  • Expert knowledge of the regulations, guidelines and standards governing observational (non-medical) research and research ethics, including the Tri-Council Policy Statement (TCPS), US Code of Federal Regulations (DHHS), Personal Health Information Protection Act (PHIPA), and privacy legislation;
  • Experience with research ethics review processes and ideally with the operational environment for research ethics review;
  • Tactful, diplomatic and professional in dealing with diverse stakeholder groups;
  • Ability to work independently but contribute effectively and positively in a team environment;
  • Excellent communication skills (oral and written);
  • Effective organizational and project planning/tracking skills;
  • Strong attention to detail;
  • Ability to prioritize and work effectively under pressure to meet deadlines;
  • Excellent judgment, interpersonal skills and problem-solving skills;
  • Experience in standard operating procedure/policy development, training program development and project implementation preferred;

 

Please submit applications with cover letter and salary expectations by December 17th, 2020 at 12:00 noon in confidence by email to: hr@ctontario.ca 

 

For further information please contact:

 

 Matthew DAscanio

              Clinical Trials Ontario

661 University Avenue, Suite 460

MaRS Centre, West Tower

Toronto, Ontario | M5G 1M1

Tel:  416-673-6601 | Email: matthew.dascanio@ctontario.ca

www.ctontario.ca

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