Director, Research Compliance and Support Services

Reporting to the Executive Director of Research Strategy and Operations, the Director of Research Compliance and Support Services (RCSS) is responsible for creating a collaborative research environment where Compliance and Quality assurance are woven in research operations and practice.

The Research Compliance and Support Services program consists of:

1) Research Compliance: identify and minimize risks to research participants and HHS by developing and implementing a risk based compliance framework for all research conducted under the auspices of HHS. This role ensures that all HHS research activities adhere to national and international regulatory requirements, as well as ethical and institutional requirements,

2) Research Quality Assurance Support for HHS: provides oversight and vision that embeds quality into every aspect of Research at HHS and collaborates across all institutes and centres to develop processes and tools to enable this vision. This role develops, maintains and promotes a comprehensive quality assurance system for research under the auspices of HHS composed of policies, procedures, processes and infrastructure.

3) Research Support Services: provides advice and operational support to HHS Researchers, ensuring that their research staff are properly trained and integrated into the broader research administration structure. This includes facilitating recruitment, onboarding, and professional development while aligning HHS research personnel with institutional policies and compliance requirements.

The incumbent will cultivate and maintain strong relationships with internal and external stakeholders, including Global Regulatory and government agencies, Global and National Research Community and community partners.

1. Undergraduate degree in Sciences or Health related field with preference for Master’s degree,
2. Minimum of 10 years of experience in Research Compliance and Quality Assurance Management,
3. Minimum of 5 years of progressive Leadership experience,
4. Understand the principles and methodological approaches required for the conduct of compliant clinical research,
5. Strong understanding of health research regulations including International Council for Harmonization (ICH), Food and Drug Administration (FDA), Health Canada (HC) and European Medicines Agency (EMA), the Tri-Council Policy Statement (TCPS-2) , Good Clinical Practice (GCP) Guidelines, National Institutes of Health (NIH) compliance framework, as well as local (HiREB) and provincial (Clinical Trials Ontario) Research Ethics Boards (REBs) and other regulatory frameworks as applicable, 
6. Ability to synthesize knowledge of complex regulatory frameworks and translate it into processes, policies and procedures to assure compliance,
7. Ability to apply general regulatory requirements to specific operational situations,
8. Ability to conduct research compliance investigations and audits with tact and diplomacy,
9. Ability to assess information gathered via investigations and audits, provide meaningful feedback and recommend a reasonable mitigation plan that aligns with regulations and institutional risk tolerance,
10. Ability to articulate and promote an overarching vision for compliance and quality assurance at HHS that motivates HHS leaders and investigators to support the mandate,
11. Training on ICH GCP, FDA, Health Canada and Tri-Council Policy Statement,
12. Project Management certification.