Clinical Study and Regulatory Assistant

Union: NON-UNION
Number of Vacancies: 1
Site: Toronto General Hospital
Department: Research
Reports to:  Clinical Lead Research & AI
Hours: 37.5 Hours Per Week
Shifts: Mon-Fri Day Shifts
Status: Temporary Full-Time
Closing Date: July 23 2025

Job Summary:
In collaboration with teams across University Health Network the AI Hub is working to transform cancer care through PMATCH a project aiming to connect patients to suitable clinical trials in a timely and personalized way. The AI Hub is leveraging large language models to extract discrete data from unstructured clinical text. To evaluate this work coordinated human evaluation of the models outputs is required. As this planned evaluation calls for high volumes of manually curated data to act as a comparator there is a need for a new Clinical Study and Regulatory Assistant to support.

The Clinical Study and Regulatory Assistant participates in the collection and curation of clinical research data for studies in support of the teams advancements in data element extraction. Principal responsibilities include reviewing redacted medical charts for relevant information recording clinical data into electronic case report forms (eCRFs) and ensuring the quality and integrity of the data collected. The coordination of data is performed in accordance with the selected data schema hospital and departmental guidelines and professional standards of practice. All data must be completed in an accurate and timely manner. Quality assurance procedures are utilized to ensure high quality data is obtained. Working closely with the Clinical Lead for Research and AI the Clinical Study and Regulatory Assistant also undertakes study-related administrative tasks such as organizing meetings taking minutes obtaining signatures and helping to prepare presentations and submissions.

Qualifications :

• At minimum a completion of a Bachelors degree program or recognized equivalent in Health or Science-Related Discipline
• Demonstrated relevant clinical research knowledge
• High proficiency in Microsoft Excel
• Experience in oncology and/or a strong ability to comprehend medical terminology
• Experience in clinical trials and regulatory issues involving human subjects preferred
• Excellent written and verbal communication skills excellent organization prioritization skills computer skills ability to learn quickly and work independently
• Excellent interpersonal skills
• Ability to work in a self-directed environment
• Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance with UHN standards
• Ability to perform multiple concurrent tasks
• Knowledge of applicable legislative UHN and/or departmental policies
• Satisfactory attendance

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 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 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 :

Yes

Employment Type :

Contract