Clinical Study and Regulatory Specialist I

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 breadth of research, the complexity of the cases treated, and the magnitude of its educational enterprise has made UHN a national and international resource for patient care, research and education. With a long tradition of ground-breaking firsts and a purpose of "Transforming lives and communities through excellence in care, discovery and learning", the University Health Network (UHN), Canada's largest research teaching hospital, brings together over 16,000 employees, more than 1,200 physicians, 8,000+ students, and many volunteers. UHN is a caring, creative place where amazing people are amazing the world.

Union: Non-Union
Site: Princess Margaret Cancer Centre
Department: Drug Development Program, Phase 1
Reports to: Clinical Research Manager
Work Model: Hybrid
Grade: N0:06
Hours: 37.5 hours per week
Salary: $66, 924 - $83, 655 per annum. To Commensurate with experience and consistent with UHN compensation policy.
Status: Permanent Full Time
Closing Date: December 15, 2024

Position Summary

The Drug Development Program at Princess Margaret Hospital is the largest drug development program in Canada and the only centre outside of the United States to have a contract with the National Institutes of Health (NIH) for Early Phase Therapeutic studies. The Drug Development Program includes a Phase I program, focusing on studies of innovative drugs and immunotherapy, with a strong emphasis on pharmacokinetics and correlative studies. It involves a collaborative and multidisciplinary approach and is strategically designed to ensure the rapid completion of high-quality studies.

This role will work in a hybrid office environment - candidate will have the opportunity to work from home and will also have a workspace on site. The Clinical Study and Regulatory Specialist I participates in the coordination of clinical trials, from the time of the initial submission to the Research Ethics Board up until study activation.

Duties

• Preparation of initial submissions and if applicable and amendments to the Research Ethics Board
• Create Informed Consent Forms and prepare other source documents required for study initiation
• Collaborate with third party sponsor and/or CRO companies to address any problems/issues that may arise during pre-site activation or during study start-up activities
• Liaise and negotiate timelines/workflow with various internal and external stakeholders in accordance with ICH-GCP, FDA, and US federal code, and Tri-Council regulations

• At minimum, a completion of a Bachelor's degree program, or recognized equivalent in Health or Science Related Discipline
• At least two (2) year experience in some or all of Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects
• Working knowledge of REB submissions and ICF creation
• 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
• Certification as a Clinical Research Professional, 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.