Clinical Study and Regulatory Specialist I

University Health Network View all jobs

  • Toronto, ON
  • $68,932-103,409 per year
  • Contract
  • Full-time
  • 1 day ago
Company DescriptionUHN is Canada's #1 hospital and the world's #1 publicly funded hospital. With 10 sites and more than 44,000 TeamUHN members, UHN consists of Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute, The Michener Institute of Education and West Park Healthcare Centre. As Canada's top research hospital, the scope of biomedical research and complexity of cases at UHN have made it a national and international source for discovery, education and patient care. UHN has the largest hospital-based research program in Canada, with major research in neurosciences, cardiology, transplantation, oncology, surgical innovation, infectious diseases, genomic medicine and rehabilitation medicine. UHN is a research hospital affiliated with the University of Toronto.UHN's vision is to build A Healthier World and it's only because of the talented and dedicated people who work here that we are continually bringing that vision closer to reality.Job DescriptionUnion: Non-Union
Number of Vacancies: 2
New or Replacement Position: New
Site: Princess Margaret Cancer Centre
Department: BRAS Drug Development Program - Phase II
Reports to: Clinical Research Manager
Salary Range: $68,932 - $103,409 Annually
Hours: 37.5 Hours Per Week
Shifts: Day Shift
Status: Permanent Full-time
Closing Date: April 30, 2026Position Summary:
The Drug Development Program at Princess Margaret Cancer Centre is the largest new drug development program in Canada and the only center outside of the United States to have a contract with the National Institutes of Health (NIH). The Drug Development Program includes a Phase II program, focusing on studies across all the various phases of trials with a strong emphasis on pharmacokinetics, translational studies and Investigator Initiated Trials. It involves a collaborative and multidisciplinary approach and is strategically designed to ensure the rapid completion of high quality studies.Duties:
  • Coordinates studies from activation to close-out
  • Ensure the collection and monitoring of data is performed in accordance with the trial protocol, hospital and departmental guidelines and professional standards of practice
  • Collect and abstract data from source documents.
  • Monitoring of data and preparing submissions to Health Canada and Research Ethics
  • Ensure all data is complete, accurate, timely and must be in compliance with applicable ICHGCP, FDA and US federal code and Tri-Council regulations.
  • Be able to interpret the applicable regulations in order to ensure compliance .
  • Responsible for study-related administrative tasks
  • Collaborate with cooperative groups, pharmaceutical companies or used for internal PMH studies
Qualifications
  • At minimum, a completion of a Bachelor's degree program, or recognized equivalent in Health or Science Related Discipline
  • At least 1-2 years' experience in some or all of Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects
  • Some experience with Health Canada regulatory submissions and site management
  • Demonstrated relevant clinical research knowledge
  • Excellent written and verbal communication skills, excellent organization, prioritization skills, good computer skills, ability to learn quickly and work independently
  • Excellent interpersonal skills, Satisfactory attendance
  • Ability to work under pressure and attention to detail
  • Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance to UHN standards
  • Ability to perform multiple concurrent tasks
  • Knowledge of applicable legislative, UHN and/or departmental policies
  • Client service oriented, with the ability to effectively work with diversity and appreciate that people with different opinions, backgrounds and characteristics bring richness to the challenge or situation at hand
  • Certification as a Clinical Research Professional, preferred
Additional InformationWhy 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 is the comprehensiveness of these offerings that makes it a differentiating factor, allowing you to find value where it matters most to you, now and throughout your career at UHN.
  • Competitive offer packages
  • Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP
) * Close access to Transit and UHN shuttle service
  • A flexible work environment
  • Opportunities for development and promotions within a large organization
  • Additional perks (multiple corporate discounts including: travel, restaurants, parking, phone plans, auto insurance discounts, on-site gyms, etc.)
Current UHN employees must have successfully completed their probationary period, have a good employee record along with satisfactory attendance in accordance with UHN's attendance management program, to be eligible for consideration.All applications must be submitted before the posting close date.UHN uses email to communicate with selected candidates. Please ensure you check your email regularly.Please be advised that a Criminal Record Check may be required of the successful candidate. Should it be determined that any information provided by a candidate be misleading, inaccurate or incorrect, UHN reserves the right to discontinue with the consideration of their application.UHN is an equal opportunity employer committed to an inclusive recruitment process and workplace. Requests for accommodation can be made at any stage of the recruitment process. Applicants need to make their requirements known.We thank all applicants for their interest, however, only those selected for further consideration will be contacted.

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