Clinical Study and Regulatory Assistant

Union: NonUnion 
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: $52182 $65228 annually (To commensurate with experience and consistent with UHN compensation policy)
Shifts: Monday Friday
Status: Permanent Fulltime
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 investigatorinitiated studies and industrysponsored trials which provide the opportunity to apply a wide breadth of skills and knowledge in regulatory startup activities and maintenance. Our team acts as the sponsor in several multisite 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 studyrelated 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 studyspecific trackers and study tools 
• Scheduling onsite/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 closeout phase of clinical study protocols as well as archival of study documents 
• Maintains annual renewal of REBs 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 
• Setup and maintenance of regulatory and study documentation 

Qualifications :

• A community college diploma in a healthrelated discipline or equivalent (required)
• Completion of a Bachelors degree program or recognized equivalent in Health or ScienceRelated 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 highquality 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

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.)

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 :

Fulltime