Clinical Study and Regulatory Specialist I

Union: NonUnion
Number of Vacancies: 1
Site: Princess Margaret Cancer Centre 
Department: BRAS Drug Development Program Phase II 
Reports to: Clinical Research Manager 
Work Model: Hybrid
Hours: 37.5 Hours Per Week
Shifts: Day Shift
Status: Temporary Fulltime
Closing Date: May 14 2025

Position Summary:

The Drug Development Program at Princess Margaret Cancer Centre is the largest new 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). 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 closeout
• 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 TriCouncil regulations.
• Be able to interpret the applicable regulations in order to ensure compliance .
• Responsible for studyrelated administrative tasks
• Collaborate with cooperative groups pharmaceutical companies or used for internal PMH studies

Qualifications :

• At minimum a completion of a Bachelors degree program or recognized equivalent in Health or Science Related Discipline
• At least 12 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
• 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

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 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 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 onsite gyms etc.)

Current UHN employees must have successfully completed their probationary period have a good employee record along with satisfactory attendance in accordance with UHNs 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.

Remote Work :

No

Employment Type :

Contract