Research Ethics & Regulatory Specialist

Are you passionate about advancing healthcare research while safeguarding the rights, dignity, and privacy of participants? Join Fraser Health as a Research Ethics & Regulatory Specialist, where your expertise will directly support ethical, compliant, and high-quality research that impacts communities across the region.

In this pivotal role, you will help shape and strengthen ethical research practices by implementing and evaluating policies and processes that ensure compliance with international, national, and provincial regulations. You’ll work at the heart of the Fraser Health Research Ethics Board (FHREB), helping researchers and the organization meet their obligations while maintaining the highest standards of participant protection.

As a trusted subject matter expert, you will:

• Lead the ethical review process from submission through approval and ongoing monitoring, ensuring all applications meet established criteria and timelines.
• Provide expert guidance on complex regulatory frameworks including TCPS, ICH-GCP, Health Canada, FDA requirements, and privacy legislation such as FOIPPA.
• Drive continuous improvement by analyzing emerging legislation and best practices, and delivering actionable recommendations to leadership and the FHREB.
• Support a culture of ethical excellence, enabling researchers to conduct innovative studies with confidence and integrity.

This is an ideal opportunity for a professional with a strong background in health research and a passion for ethics, bringing at least five years of experience in a research-focused healthcare environment. Your ability to interpret and apply regulations, paired with your attention to detail and collaborative approach, will position you as a key contributor to Fraser Health’s research ecosystem.

Why Fraser Health?
At Fraser Health, you’ll be part of a forward-thinking organization committed to innovation, integrity, and improving health outcomes. You’ll work alongside dedicated professionals who value ethical research as a cornerstone of patient care and discovery.

Make an impact where it matters most—help ensure research is conducted responsibly, safely, and with purpose. Join Fraser Health today.

#LI-DNI 

1. Implements and evaluates process and policy changes to support Fraser Health Research Ethics Board (FHREB), Fraser Health's and Fraser Health researchers' compliance with applicable international, Canadian and provincial laws and standards, standard operating procedures and Fraser Health policies that affect the role and actions of the FHREB and obligations of Fraser Health Authority, Fraser Health employees and physicians and affiliated researchers, to ensure the protection of human research participants and/or their personal information.
2. Administers the Fraser Health ethical review process on behalf of the FHREB, from submission to approval and continuing review. Ensures all applications for ethical review meet applicable criteria; conducts a pre-review of the ethics submission documents according to FHREB standard requirements prior to submission to FHREB, according to standard timelines.
3. Maintains current knowledge regarding international, national, provincial and local legislation, policy and standards of practice/guidelines that apply to research involving humans; prepares issue summaries and recommendations for the Director and the FHREB.
4. Provides operational support to FHREB meetings by methods such as the following:  develops briefing notes and presentations as required; prepares agendas for the FHREB, in consultation with the Director and the FHREB Chairs; takes meeting minutes of the FHREB meetings and ensures the minutes are consistent with the post-review correspondence from the FHREB to the principal investigator for each research study; develops supporting briefing notes and presentations as required; determines appropriate action regarding issues identified in committee minutes and drafts all necessary correspondence; prepares correspondence that reflects the applicable review decision of the applicable review to the principal investigator, within standard timelines. Ensures decisions are entered into the research administration database.
5. Conducts delegated reviews of and approvals for minimal risk research as delegated by the FHREB. This includes new applications, amendments and renewals and close-out reports.
6. Monitors membership of the FHREB to ensure membership requirements of Health Canada, United States Common Rule, and the Tri-Council Policy on the Ethics of Conducting Research Involving Humans are met; ensures that terms of reference, quorum appointment processes, conflict of interest requirements and international registration requirements are also adhered to. Provides feedback and recommendations regarding any issues arising to the Director and implements recommendations with approval of Director.
7. Develops, implements and evaluates education and training regarding the process of ethical review and its requirements for the FHREB members, Fraser Health researchers and medical and pharmacy residents, as part of the Department of Evaluation and Research Services (DERS) education program, and provides consultation as required.
8. Monitors and is accountable for allocated FHREB expense budgets and supports Director with research budget management projects . Ensure applicable ethics fees are collected and that FHREB member honoraria and other expenses are paid.
9. Oversees the mock Health Canada inspection program for research sites and the FHREB. Ensures recommendations for improvement are brought to the FHREB for specific studies. Coordinates periodic preparedness exercises for Health Canada inspections in consultation with the clinical research community. Develops and implements systems to audit compliance of principal investigators with requirements for annual renewal.
10. Applies quality improvement processes and incorporates best practices on an annual basis to FHREB standard operating procedures in order to improve work flow and ensure processes are updated. Collaborates with appropriate Fraser Health departments and external affiliated researchers to identify improvements in the electronic application process, and coordinates with FH Privacy and IM/IT departments regarding implementation of improvements to the privacy and security approval processes.
11. Assists researchers with the preparation of ethics applications/protocols/forms. Updates/revises forms for applications, guidance notes, consent form templates and other applicable templates as required.
12. Compiles data for interim reports and the annual report to the FH Board of Directors. Conducts random audits of the research administration database and filing system to ensure data accuracy.
13. Maintains FH Ethics web page by developing and providing content for submission. 
14. Represents Fraser Health on committees such as the BC Ethics Harmonization Advisory Committee in order to contribute to the development of province-wide strategies, policies and procedures for harmonization of ethics review, participates on national ethics-related committees to provide input to the requirements of the Tri-council's policies, and other committees as required.