Research Agreement Specialist

2 weeks ago

University, Canada University Health Network Full time
Full-time

  • Department: Other (Not Listed)

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

Union:
Non-Union

Site:
OPG 700 University

Department:
Clinical Trial Agreements Office

Reports to:
Manager, Clinical Trial Agreement Office

Grade:
N0:08

Hours: 37.5 hours per week

Salary:
Commensurate with experience and consistent with UHN Compensation Policy.

Shift:
Monday - Friday

Status:
Permanent Full-time

Closing Date October 31, 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 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 the UHN and UHN research participants.


Position Summary
The Research Agreement Specialist is an essential part of preparing and negotiating legal agreements for UHN research studies.

Duties

  • Drafting/reviewing, negotiating, and administering a high volume of clinical trial agreements, research contracts/subcontracts, material transfer agreements, datasharing agreements, and agreements with collaborating institutions, research consortia, nonprofit organizations, affiliated institutions, and other universities.
  • Develop agreement strategies and also review and assess study submissions by researchers to determine study complexity and requirements.
  • Engage with key internal stakeholders such as the Research Ethics Board, Research Financial Services and senior management for briefing and decisionmaking.
  • From beginning to end, the Research Agreement Specialist must be able to manage institutional risk and provide effective and efficient service and support to researchers.
  • The development of SOPs and review tools.

Qualifications:

  • At minimum, completion of a bachelors degree in law, business or science required; Master's degree preferred;
  • At minimum three (3) years of practical and related experience with at least 1 year on the job training.
  • 1 year of experience drafting, interpreting and negotiating agreements and strong knowledge of contract clauses and legal, compliance, and risk assessment concepts
  • Minimum one (1) year experience of practical and related experience with clinical trial agreements, data transfer agreements, confidentiality agreements, study orders etc.
  • Minimum one (1) year of practical and related experience with adaptive clinical trials
  • Working knowledge of relevant Canadian legislation, regulations and guidelines such as PHIPA, CAHO as well as international privacy laws such as GDPR, etc.
  • Working knowledge of public and private organisation grants and funding terms such as CIHR, NIH, The Michael J. Fox Foundation, etc.
  • Knowledge of risk management principles
  • Ability to manage and prioritize projects simultaneously; to efficiently communicate, write, edit, analyze, negotiate and problem solve
  • Familiarity with and/or experience in contracts or in an academic research environment is required
  • Demonstrated negotiation and facilitation skills
  • Experience in a Microsoft Office environment preferred
  • Knowledge of the Sophia Knowledge Management System (WellSpring) and Adobe Sign are an asset
  • Excellent verbal and written communication skills required
  • Excellent interpersonal and customer service skills required
  • Attention to detail/analytical thinking and excellent organizational abilities required
  • Ability to manage personal timelines and priorities with mínimal supervision required
This role supports a hybrid work environment, splitting time between the office

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