Manager, Clinical Trials Agreement Office - Toronto, Canada - University Health Network

Sophia Lee

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Sophia Lee

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Description

Company Description

The University Health Network, where "above all else the needs of patients come first", encompasses Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute and the Michener Institute of Education.

The University Health Network is committed to high quality and equitable care for all patients.

UHN recognizes the significant barriers to accessing care that continue to exist for Indigenous Peoples (First Nations, Inuit and Métis) and is committed to addressing these gaps by advocating for culturally safe, high quality, trauma-informed care that is free of racism and discrimination for all Indigenous patients.

It is also committed to supporting the well-being of Indigenous staff, learners and health care providers so that they can learn and work in an environment that respects and values their Indigenous identities


Job Description Union**:
Non-Union


Site:700 University Ave


Department:
Research Legal - Clinical Trial Agreements Office


Reports to:
Director


Hours: 37.5 hours per week


Salary:
Commensurate with experience and consistent with UHN compensation policy


Status:
Permanent Full-Time


Posted Date:
May 08, 2024


Closing Date:
June 07, 2024


About the Clinical Trial Agreements Office


The Clinical Trial Agreements (CTA) Office is a large and expanding department situated within Research Legal and falls under the provision of both Corporate Legal and Research Solutions & Services (RSS) at UHN.

The CTA office helps to facilitate approximately 2,000 contracts a year for research involving human participants.

Thousands of research studies are undertaken at UHN every year.

While some involve UHN researchers and clinicians only, most involve third-parties such as pharmaceutical and medical device companies, government or funding agencies, contract research organizations and other research institutions.

It is imperative that appropriate legal agreements are in place to govern these relationships as well as to manage and mitigate risk to UHN and its research participants.


Position Summary
As the Manager of the CTA Office, you are responsible for: i) providing direction, coordination and oversight to research agreement specialists under direct supervision: ii) ensuring that clinical research contracts are managed effectively within UHN, and iii) working closely with a variety of stakeholders in order to ensure that contracts are processed efficiently and in compliance with all relevant legal and regulatory requirements.

The Manager is the primary point of contact for the following:


  • UHN clinical research stakeholders (such as Principal Investigators, Clinicians, Research Coordinators, Research Managers and other research personnel)
  • Other UHN Departments/Divisions (such as Commercialization, UHN Legal, Privacy, Research Ethics Board, CAPCR)
  • External (i.e. nonUHN) corporate commercial (industry) partners, nonprofit, and academic partners.

Responsibilities

  • Support the Director, Research Legal in maintaining and monitoring the clinical research related legal and contractual obligations of UHN.
  • Managing the overall workflow of the Clinical Trial Agreements Office.
  • Perform reputational and institutional risk management activities.
  • Hiring, promoting, disciplining and terminating staff, as required.
  • Providing direct supervision, oversight and direction to Research Agreements and coordination to contract specialists to effectively manage high volume agreements with timely response.
  • Maintain knowledge/understanding and currency in diverse areas of UHN practice in respect of clinical trials (such as privacy, consents, regulatory requirements, tissue ownership, contracts).
  • Use data analysis and stakeholder input to identify areas for CTA Office improvement.
  • Establish metrics to track process performance and regularly report progress and results to senior management.
  • Lead process of modernization, automation, and standardization efforts to align process improvements with Research Strategic Initiatives, and evaluate Clinical Trial Agreements Office review procedures.

Qualifications

  • At minimum, Master's or advanced degree in law, business, science or related field required
  • Demonstrate relevant clinical research knowledge
  • At minimum, over 46 years of practical and related experience, and 23 years supervisory/management experience.
  • Excellent written and verbal communication skills, excellent organization, prioritization skills, good computer skills, ability to learn quickly and work independently
  • Membership in Canadian clinical research association is not required but attendance in clinical research conferences on an as needed basis is encouraged.

Additional Information Why join UHN?**In addition to working alongside some of the most talented and inspiring healthcare professionals in the world, UHN offers a wide range of benefits, programs and perks. It i

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