Manager, Human Research Ethics

Employee Group PMA
- Professional and Managerial Association About Western Since 1878, Western University has been committed to serving our communities through the pursuit of academic excellence and by providing students, faculty, and community members with life-long opportunities for intellectual, social, and cultural growth. We seek excellent students, faculty, and staff to join us in what has become known as the "Western Experience"
- an opportunity to contribute to a better world through the development of new knowledge, new abilities, new connections, and new ways to make a difference.

About Us
Western Research provides strategic and administrative support to foster a culture of research excellence that enhances Western University's profile on the global stage. Responsibilities The Manager, Human Research Ethics will provide operational leadership for Western's Human Research Ethics program, ensuring efficient, consistent and compliant administration of research ethics processes supporting both clinical and non-clinical human research. Reporting to the Director, Research Ethics and Compliance, the Manager will oversee and manage the day-to-day operations of the Office of Human Research Ethics (OHRE) and related procedures, provide expert advice regarding complex research ethics matters, and support timely, consistent, and risk-informed decision making in accordance with institutional policies, provincial and federal legislation, and national research ethics standards. The role will lead a team of research ethics professionals and staff, promote research excellence through continuous process improvement and standardization, and develop practical resources, training and guidance that support researchers, Research Ethics Boards (REBs), and the broader research community. The Manager will also provide leadership for research ethics systems, operational quality improvement initiatives, and the implementation of new processes and programs that enhance the efficiency and effectiveness of the human research ethics program while safeguarding research participants and institutional accountability. Qualifications

Education:
- Master's Degree in a health sciences, clinical research, research administration, or related discipline
- TCPS2 CORE Certification
- Good Clinical Practice (ICH-GCP) certification from a recognized provider (e.g., CITI, N2/CANTRAIN, ACRP, SOCRA) is preferred
- Additional certification in research ethics or research administration would be considered an asset

Experience:
- 7 years of experience in the following:
- Progressively responsible experience in human research ethics and/or clinical research administration supporting clinical research ethics reviews
- Demonstrated experience interpreting and applying TCPS2, Good Clinical Practice (ICH-GCP), applicable federal and provincial legislation and regulations, privacy legislation (including PHIPA), Health Canada requirements, U.
S. Common Rule and FDA regulations, and institutional policies governing human participant research
- Experience supervising professional staff and leading operational teams
- Experience implementing operational improvements, standard operating procedures and quality improvement initiatives
- Experience working with electronic research ethics management systems (e.g., WREM, or similar platforms) Knowledge, Skills & Abilities:
- Expert knowledge of TCPS2 and Canadian human research ethics frameworks
- Advanced knowledge of applicable federal and provincial legislation, regulations, and privacy requirements governing human participant research, including PHIPA
- Advanced knowledge of Good Clinical Practice (ICH-GCP), Health Canada requirements, and other regulatory frameworks applicable to clinical research and clinical trials
- Knowledge of international ethical and regulatory requirements governing human participant research, including the U.
S. Common Rule and FDA regulations, where applicable
- Extensive knowledge of Research Ethics Board operations, governance, review processes (e.g., full board, delegated, multi-jurisdictional, etc.), and oversight requirements for human participant research
- Strong understanding of clinical research methodologies and regulatory requirements
- Exceptional judgment and decision-making skills, particularly in complex or ambiguous situations
- Strong leadership, coaching and conflict resolution skills
- Demonstrated ability to balance operational priorities while managing multiple competing deadlines
- Excellent analytical, written and verbal communication skills
- Proven ability to build collaborative relationships with researchers, clinicians, administrators and external stakeholders
- Strong project management and continuous improvement skills
- Ability to maintain and develop an effective network of contacts that provide information regarding emergent opportunities and best practices in the field of human research ethics
- Communication skills wi