Clinical Study and Regulatory Assistant

UHN 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.

www.uhn.ca

Union: Non-Union
Site: Princess Margaret Cancer Centre
Department: Radiation Medicine Program - Clinical Research Program (CRP)
Reports to: Clinical Research Manager
Work Model: Hybrid
Grade: N0:03
Hours: 37.5 hours per week
Salary: $52,182 - $65,228 annually (To commensurate with experience and consistent with UHN compensation policy)
Shifts: Monday - Friday
Status: Permanent Full-time
Closing Date: February 28, 2025

Position Summary
We are seeking a highly motivated individual to work in the Radiation Medicine Program (RMP), joining our team of clinicians, scientists, and support personnel as a clinical research Regulatory Assistant. The ideal candidate is well organized and able to prioritize and multitask between multiple competing duties while contributing as an effective team player.

Our portfolio of studies includes investigator-initiated studies and industry-sponsored trials which provide the opportunity to apply a wide breadth of skills and knowledge in regulatory start-up activities and maintenance. Our team acts as the sponsor in several multi-site trials requiring strong project management skills.

Duties

• Organizes and conducts SIV and protocol reviews
• Participates in the planning and implementation of clinical research protocols
• Identifies and logs protocol and SOP deviations
• Prepares submissions (amendments, reportable events, annual renewals, study closures) to REB
• Executes study-related administrative tasks, such as collection and maintenance of regulatory documents, ethics submissions, protocols, staff training and delegation logs in paper and electronic formats, Maintenance & modification of study-specific trackers and study tools
• Scheduling on-site/virtual monitoring visits and collecting necessary source documentation
• Liaises between site and sponsor to ensure that documentation and information are distributed to relevant staff
• Ensures and maintains regulatory compliance
• Coordinates the close-out phase of clinical study protocols as well as archival of study documents
• Maintains annual renewal of REB's for the program portfolio
• Submission of retrospective studies into CAPCR
• Supports the trial activation process - following up with task assignments per the target timeframe and collation of documents
• Assist in drafting Informed Consent Forms
• Set-up and maintenance of regulatory and study documentation

• A community college diploma in a health-related discipline, or equivalent (required)
• Completion of a Bachelor's degree program, or recognized equivalent in Health or Science-Related Discipline is preferred
• 3 to 6 months related experience in some or all of Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects is required
• 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
• 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
• Satisfactory attendance
• Clinical Research Graduate Certificate, preferred

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 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 https://hoopp.com/)
• 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.