Research Compliance Specialist

2 weeks ago

Regina, Canada University of Regina Full time

Faculty/Department VP Research Unit Research Office Employee Group URFA APT Collective Agreement Consideration Open with preference given to APT members. CUPE 5791 Job Family Category Staff Number of Vacancies 1 Position Summary

**Position Summary**:
The Research Compliance Specialist, reporting to the Director, Office of Research Services, is responsible for ensuring that all research conducted under the auspices of the University of Regina complies with Federal, Provincial, and Institutional policies, guidelines, legislation, and best practices. This position is required to develop and manage an effective institutional-wide compliance program, coordinating and providing ethics and regulatory monitoring, expertise, resources, support, advice and training for University of Regina research activities to ensure the University remains in compliance with legal, quality and ethical compliance requirements, as well as industry best practices.

**Primary Responsibilities**:

- Write and revise policies, implement procedures and update forms, ensuring compliance with new and revised human research guidelines and regulations and other best practices for research involving humans, their data or biological materials.
- Maintain and update international registrations of the REB such as the Federal Worldwide Assurance which is required for international research projects.
- Review project documents for risk assessment and completeness, where necessary issuing pre-review comments to ensure the review process at the Chair or board level will not be held up or facilitating if there are specific requirements that researchers may not have considered such as legal agreements
- Review and approve all ongoing review for research
- Recruit new members and Chairs from the University and larger community in order to ensure that the REB is representative of all Faculties and the community and aligns with TCPS 2 guidelines for REB membership.
- Ensure that all REB documentation is retained appropriately, including all review material including board and sub-committee meeting minutes, correspondence and that regular monitoring of studies is done, including investigating participant concerns or complaints, deviations from approved protocol procedures or reported cases of misconduct.
- Leads the investigation of serious participant concerns or complaints, protocol deviations or potential cases of misconduct and escalates these if necessary.
- In case of an appeal of an REB review, the Research Compliance Specialist facilitates the VP of Research REB Appeal Process (compiles all review documentation and assists the appointed Appeal Committee with the review process as required).
- Implementation and management of the University compliance framework, including relevant policies, procedures, processes, guidelines and controls.
- Provides updates and presentations to the Council Committee on Research regarding the external review of the Research Ethics Board and to provide demonstrations of the Converis Research Information System.
- Provides coverage to other Research Compliance Specialists

Position Requirements

**Position Requirements**:

- A graduate degree. An equivalent combination of education & experience will be considered.
- Completion of the TCPS2 Course on Research Ethics (CORE Tutorial), Animal Care Training Modules, Good Clinical Practice course.
- 5 years’ experience in research compliance, or equivalent.
- Knowledge of the applicable regulatory legislation (provincial and national privacy regulations, Health Canada regulations) and ethical guidelines nationally and internationally
- Broad knowledge of ethics and the potential applicability of those principles within different disciplines and the ability to foresee immediate and potential risks for participants, the community, researchers and the University as an institution
- Strong background in Research Ethics and a wide range of research methodology, as well as applicable guidelines and regulations.
- Ability to present in graduate level courses to teach the need for ethics and help prepare students for their upcoming submissions to the Research Ethics Board.
- Ability to write institutional reports for audiences such as Health Canada and various compliance committees
- Excellent verbal and written communication skills and the ability to remain empathetic and maintain a reputation of being approachable and collaborative
- Problem solving skills
- Ability to prioritize tasks, meet deadlines and manage multiple projects simultaneously.
- Ability to think critically, and demonstrate problem solving and analytical skills.
- Must possess strong social interaction and communication skills with various audiences

Physical Demands Pay Grade APT 6 Salary Range $69,536 - $93,824 Annually Status Permanent Work Hours

Monday - Friday 8:15am - 4:30 pm, occasional work on evenings and weekends may be required.

Duration (if Term/Temporary) Full-Time/Part-Time Full Time Preference

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