Conduct regulatory review processes for all investigator-initiated regulated research submitted to the

Research Ethics Board (REB) and Health Canada for review

Conduct comprehensive centralized review and approval for all CHEO investigator-initiated applications, and ongoing communications/submissions to Health Canada to ensure accuracy and facilitate regulatory compliance

Facilitate regulatory inspections across the Institution by ensuring research teams and hospital support areas are prepared

Act as a consultant/expert resource to advise, guide, educate and train the CHEO clinical research community regarding methods to maintain high standards of quality research, and the mitigate potential risks arising from the conduct of clinical research, by sharing and educating staff about regulations, guidelines, and best practices

Communicate and promote the use of institution-wide standard operating procedures for the conduct of clinical research

Develop and maintain templates and resources to guide clinical research staff in the conduct of clinical research to facilitate regulatory compliance

Liaise with research team members (locally and/or at study sites), REB staff, CHEO Grants, Contracts and Finance staff, study sponsors and others as required

Identify ongoing education and support needs of the CHEO research community

Deliver education sessions to clinical research staff on a variety of topics, including Clinical Trial

Applications, International Conference on Harmonization – Good Clinical Practice (ICH-GCP), SOPs, Part C Division 5, privacy regulations (provincial and federal), best practices, etc.

Maintain current distribution lists for regulated researchers and research professionals

Develop and maintain content for the CHEO RI Web pages

Work with the CHEO Epic team to facilitate access for external monitors

Perform other related duties as assigned by Manager

QUALIFICATIONS, SKILLS AND ABILITIES

Bachelor’s degree Essential

Advanced degree in Health Sciences, Health Care Administration, or another related field Preferred

Current Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Preferred