Job Description

Director - Human Research Protections Program (HRPP) - Regular Full-Time (231883) Toronto, ON, CA Posted: 5/26/2023 3:54:33 PM

We currently have a Regular Full-Time opportunity for a Director for the Human Research Protections Program (HRPP), located at our Bayview Campus.

Hours of Work:

Weekdays: Days; 8 hrs; as per schedule

The Director for the Human Research Protections Program (HRPP) reports directly to the Vice President Research and Innovation and works closely with the Sunnybrook Research Ethics Board (REB) Chair.

The Director is responsible for the oversight of day to day operations of the HRPP including accountability for leadership, strategic planning, financial and risk management, continuous improvement, policies and procedures, and human resources as outlined below (not meant to be all encompassing). In support of Sunnybrook\xe2\x80\x99s mission and the Terms of Reference of the REB, the Director responsibilities include:

Leadership, Strategy and Management:

• Sets the vision and leads Sunnybrook\xe2\x80\x99s comprehensive human research protections program
• Provides exceptional leadership for the Sunnybrook research community
• Builds strategic relationships and partnerships both within and externally to Sunnybrook
• Engenders a culture of customer service excellence
• Establishes, executes and maintains program policies and procedures
• Ensures regulatory risk to institution is mitigated
• Collaborates with Sunnybrook Research Institute (SRI) and hospital leadership, including but not limited to Legal Services; SRI finance; SRI IT; Strategic Research Programs; Technology Transfer Office, Communications, Operations Directors to address develop and implement necessary work products as they arise
• Informs the VPRI, REB Chair and Medical Advisory Committee of critical research ethics, quality and integrity matters
• Participate and/or lead the procurement, implementation and ongoing maintenance of the systems and procedures in support of clinical research
• Ensures Health and Safety requirements consistent with relevant legislation are met and/or exceeded
• Procedural lead for the clinical research \xe2\x80\x9cExit Process\xe2\x80\x9d for clinicians/scientists
• Responsible for compliance with accreditation guidelines and standards
• Prepares and submits an annual report encompassing HRPP activities

Responsible Conduct of Research

• Leads Sunnybrook\xe2\x80\x99s responsible conduct of research program, policies and procedures
• Ensures due process is adhered to with respect to Research Misconduct inquiries, investigations and reporting to the Secretariat on the Responsible Conduct of Research, Canada and the Office of Research Integrity, US
• Responsible lead for internal investigation processes and associated documentation in response to complaints, allegations and/or evidence of non-compliance in the conduct of human participant research

Research Ethics Board (REB) Operations

• Executes the strategic direction and operations of the Sunnybrook REB
• Ensures human research protections through excellence in research ethics review and oversight procedures
• Identifies and rectifies regulatory compliance and procedural weakness of the REB and research ethics office
• Accountable for the maintenance of Sunnybrook\xe2\x80\x99s Federal Wide Assurance (FWA) and IRB registration with the US Office of Human Research Protections
• Ensures the REB membership is appropriately constituted and compliant with applicable regulations
• Ensures Sunnybrook REB\xe2\x80\x99s ongoing qualification to act as a delegated board of record through Clinical Trials Ontario
• Represents Sunnybrook on local, provincial and national research ethics initiatives
• Develops and directs Sunnybrook/SRI responses to consultation on national standards.

Quality Assurance and Education

• Leads the development and implementation of Sunnybrook\xe2\x80\x99s clinical research quality assurance and education framework for the protection of human participants and compliant conduct of clinical research at Sunnybrook
• Accountable for ensuring quality assurance and education service objectives are met
• Determines and executes necessary program policies and procedures
• Accountable for Sunnybrook/SRI\xe2\x80\x99s conduct with respect to Health Canada and/or US FDA regulatory inspections
• Appropriately escalates risk exposure to the VPRI and Senior Leadership
• Accountable for execution of internal audits and enforcement of necessary corrective and preventative actions
• Accountable for the execution and oversight of the study impact approval process impacting hospital resources
• Responsible lead for investigation process related to unauthorized use of hospital resources for clinical research

Financial Accountability:

• Accountable for the management of annual operating budget of approximately one million dollars
• Ensures fiscal responsibility of the HRPP budget
• Accountable for expenses incurred, financial administration, reconciliations and compliance with hospital policies
• Responsible for attesting compliance with the Broader Public Hospitals Accountability Act.

Human Resources:

• Responsible for objective setting and performance of HRPP staff
• Provides leadership, direction and supervision for HRPP staff
• Responsible for Human Resources (HR) planning and management including supporting the development of role profiles, performance review, recruitment, retention, disciplinary action and terminations as per policies
• Ensures compliance with Sunnybrook Human Resources and Occupational Health and Safety policies
• Responsible for establishing and maintaining of a high performing team, and providing opportunities for professional development where appropriate, mentorship and motivation

Qualifications & Skills:

• A master\xe2\x80\x99s degree in health science, health administration, ethics, law or related preferred; equivalent education and experience may be considered
• Demonstrated experience with budget management
• A minimum of 7 years of progressive clinical research/research ethics experience including management roles(s)
• Expert knowledge of the regulations, policies and guidelines that govern human participant research and the responsible conduct of research
• Demonstrated experience building and leading programs and teams
• Demonstrated ability to be flexible and agile while efficiently supporting the organization during periods of change and shifts in strategic goals and objectives
• Demonstrated excellence in interpersonal and communication and presentation skills
• Experience presenting to senior level committees a definite asset
• Demonstrated ability to work collaboratively and supportively across programs, departments and organizations
• Demonstrated skills in problem solving and conflict resolution
• Demonstrated ability to think strategically, develop/implement action plans that achieve goals and objectives
• Possess a strong understanding and perspective of the clinical research landscape including knowledge and insight into various trends, regulatory changes and associated impact for Sunnybrook.

How to Apply:

Qualified applicants are invited to submit a resume and cover letter to the address below by June 9th, 2023.

Attn: Stani Slavova,

Diversity Statement

Sunnybrook Research Institute is committed to excellence in research and research training. Achieving a more equitable, diverse and inclusive research enterprise is essential to creating the excellent, innovative and impactful research necessary to invent the future of healthcare.

Sunnybrook Research Institute is strongly committed to inclusion and diversity within its community and

welcomes all applicants including but not limited to: women, visible minorities or persons of colours,

Indigenous peoples, people from all genders, religions and ethnicities, persons with disabilities, LGBTQ2S+ persons

and all others who may contribute to the further diversification of ideas.

Accommodation Policy

Sunnybrook Research Institute is committed to providing accessible employment practices that are in compliance

with the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation for a disability during

any stage of the recruitment process, please indicate this in your cover letter.

All qualified candidates are encouraged to apply; however, Canadians and permanent residents will be given priority.

Sunnybrook Health Sciences Centre is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation for disability during any stage of the recruitment process, please indicate this in your cover letter.

Sunnybrook Health Sciences Centre is strongly committed to inclusion and diversity within its community and welcomes all applicants including but not limited to: visible minorities, all religions and ethnicities, persons with disabilities, LGBTQ persons, and all others who may contribute to the further diversification of ideas.

Please be advised that in order to be eligible for employment at Sunnybrook, all new hires must have received the full series of a COVID-19 vaccine or combination of COVID-19 vaccines approved by Health Canada (e.g., two doses of a two-dose vaccine series, or one dose of a single-dose vaccine series); AND have received the final dose of the COVID-19 vaccine at least 14 days ago. Medical exemptions or any other kind of requested exemption based upon the Hospital\xe2\x80\x99s obligations pursuant to the Ontario Human Rights Code will be considered on a case-by-case basis.

Sunnybrook Health Sciences Centre