Clinical Study and Regulatory Specialist I

Union: NonUnion
Site: Princess Margaret Cancer Centre
Department: Drug Development Program Phase I
Reports to: Clinical Research Manager
Work Model: Hybrid
Grade: N0:06
Hours: 37.5 hours per week
Salary:  $66924 $83655 annually (To Commensurate with experience and consistent with UHN compensation policy)
Status: Permanent Fulltime 
Closing Date: December 31 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 highquality 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 protocol review and approval through to activation follow up and trial closure.

Duties

• Monitoring and promoting the quality and integrity of data and recording clinical trial data in case report forms (CRFs). The coordination and monitoring of data is performed in accordance with the trial protocol hospital and departmental guidelines and professional standards of practice. 
• All data must be complete accurate timely and must follow applicable ICHGCP FDA and US federal code and TriCouncil regulations.
• The Clinical Study and Regulatory Specialist I must be able to interpret the applicable regulations to ensure compliance. Quality assurance procedures are utilized to ensure high quality data is obtained.

Qualifications :

• At minimum a completion of a Bachelors degree program or recognized equivalent in Health or Science related discipline
• At least two (2) years experience in some or all of Oncology Clinical trials medical terminology regulatory issues involving human subjects
• Working knowledge of CTCAE electronic case report forms (eCRFs) REB submissions and ICF amendments are assets
• 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 )
• 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 onsite gyms etc.)

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 :

Fulltime