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Manager, Office Of Human Research Protections

Job IDC4-33-6C-15-B4-0E
CompanyHolland Bloorview Kids Rehabilitation Hospital
LocationToronto
ProvinceOntario
Date Posted2021-02-09
Posted Until2021-04-10
Job TypeFull-time
Job CategoryHealth Care
Description
The Manager, Office of Human Research Protections is responsible for the oversight, strategic development and operations of the Bloorview Research Institute’s (BRI) Office of Human Research Protections (OHRP) which is comprised of the Research Ethics Office and Quality, Education and Compliance Program. The OHRP is an arm of the Research Operations portfolio comprised of a multidisciplinary team. The Manager will ensure the efficient facilitation of ethics review and report on key performance indicators to the Director and other members of the BRI executive, management and hospital leadership. The Manager will promote Responsible Conduct of Research at all levels of research and lead and support the development, implementation and ongoing operations of the Quality, Education and Compliance Program utilizing internal resources, and service providers. Further, the Manager will lead a team of staff with specialized functions and be accountable for the overall financial performance of the OHRP.

As a member of the BRI’s Operations and Management team, the Manager will work closely with executives, scientists, staff, trainees, leadership, and members of the Research Ethics Board. This leadership role oversees quality and education in the BRI, through management, maintenance and on-going development of quality and process improvement initiatives, internal quality assurance monitoring, auditing and regulatory compliance and an education program including coordination and hands-on training for clinical research staff, development of educational materials and modules, and tracking and documentation of education and training.

Key Responsibilities

-Provide oversight and leadership of the Research Ethics Office and the Quality, Education and Compliance Program
-Ensure efficient, timely and complete facilitation of ethics reviews by the Research Ethics Office in a collaborative manner with the Research Ethics Board
-Provide strategic direction to the inception of the Quality, Education and Compliance Program, and ongoing development and maintenance of the Program
-Oversee the conduct of audits as appropriate
-Develop educational materials, curriculums and identify external training opportunities to enhance the knowledge base of clinical research staff within the organization
-Identify and address gaps in operations and programs within the portfolio
-Act as an information resource and provide authoritative information and advice on new policies and standards, relevant changes to regulatory requirements and policy development in clinical research
-Report and address key performance indicators using process improvement initiatives to enable excellence in quality and service
-Develop and implement organizational policies, standards and procedures that address conduct and management of clinical research
-Accountable for financial performance of the OHRP including but not limited to developing budgets, variance reports and justifications, and forecasts to ensure sustainability
-Support the technical and systems staff in the maintenance and ongoing process improvements to electronic systems for managing research ethics and institutional authorization
-Participate in strategic initiatives as a member of the BRI Management team as appropriate
-Other duties as assigned
Start DateApril 1, 2021
CredentialsCertificate in clinical research (e.g., CCRP) is preferred.
Project Management Professional designation is an asset.
Education RequirementsMasters level education in health-related field.
Essential SkillsOutstanding communication, interpersonal skills and problem-solving skills
Excellent analytical skills
Excellent judgment and adaptability
Ability to use tact and discretion
A champion of innovation and continuous improvement
Must have a strong understanding of and maintain strict confidentiality of privileged information
ExperienceMinimum three years’ experience in clinical research, including regulated clinical trials, supervision of staff and programs.
Must have experience in supervising a team of staff in a clinical research and/or healthcare setting.
Experience with industry sponsored clinical trials or in the pharmaceutical sector preferred.
Sound knowledge of core ethical principles, standards, regulations and processes in clinical research including but not limited to TCPS: Ethical Conduct for Research Involving Humans, Health Canada, FDA, ICH-GCP, PHIPA and HIPPA.
LanguagesEnglish
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