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Title

Manager, Office of Human Research Protections - BRI 

Category Management  
Req Number MAN-21-00002  
Open Date 2/9/2021  
Number of Openings 1  
Department Bloorview Research Institute 

Work type Regular Full-time 

Grade None Specified 

FTE 1.0 

Posting Close Date 03/03/2021 

Description

Title: Manager, Office of Human Research Protections

Status: Regular Full-Time (1.0 FTE)

Start Date: April 1, 2021

Reporting To: Director, Research Operations & Business Development

Program: Bloorview Research Institute

 

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
  • Acts as a representative on research ethics advisory councils as appropriate both internally and externally 
  • Provides ethics reviews of assigned new study submissions and manages study submissions until approval 
  • Other duties as assigned

Minimum Knowledge, Skills and Abilities

  • Masters level education in health-related field.
  • Certificate in clinical research (e.g., CCRP) is preferred.
  • Project Management Professional designation is an asset.
  • Minimum three years’ experience in clinical research, including regulated clinical trials, supervision of staff and programs.
  • Experience working with centralized or local research ethics boards 
  • 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.
  • Experience with paediatric research 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.
  • Outstanding 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
 
About the Organization Holland Bloorview Kids Rehabilitation Hospital creates a world of possibility by supporting children and youth with disabilities, medical complexity, illness and injury. All of our work is guided by our strategic plan, Transformative Care, Inclusive World: Holland Bloorview 2030. The plan: https://strategicplan.hollandbloorview.ca/

To get a glimpse as to who Holland Bloorview is, we invite you to watch the Dear Everybody, This is Holland Bloorview video. Video: https://www.youtube.com/watch?v=kbp-WhflXXo&feature=youtu.be

Holland Bloorview is committed to fostering a climate of inclusion, diversity, equity accessibility, and anti-racism (IDEAA). This commitment is central to, and mutually supportive of, our research excellence mandate. We welcome and respect the diversity of all members of our community and we seek to create an inclusive culture for our clients, families, research scientists, staff, participants, trainees, volunteers, trustees, and partners. To help in our journey towards fully reflecting the communities we partner with, we welcome and encourage applications from Black individuals and other racialized persons, Indigenous Peoples, women, persons with disabilities, LGBTQI2SA+ persons, and others who may contribute to further diversification of ideas within our community. Holland Bloorview is committed to fair assessment of a candidate's abilities, and consideration for diversity of thought, method, and experience, including non-traditional career paths.

In accordance with the Accessibility for Ontarians with Disabilities Act, accommodation will be provided throughout the recruitment process to applicants with disabilities. Please notify us of any accommodations that you require by contacting humanresources@hollandbloorview.ca or 416-425-6220.  

This position is currently not accepting applications.

To search for an open position, please go to http://hollandbloorview.appone.com



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