Clinical Study and Regulatory Specialist I

The Clinical Trial Support Unit (CTSU), University Health Network is looking for a Clinical Study and Regulatory Specialist I to work with its EDC building team for the oncology and hematology clinical trial portfolio. The CTSU runs a broad spectrum of therapeutic trials across all types of malignant disease. The CTSU is part of the Cancer Clinical Research Unit (CCRU) which provides various learning opportunities via its Education and Quality Assurance Program.

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. Principal responsibilities include research ethics board submissions, regulatory file maintenance, monitoring and promoting the quality and integrity of data and recording clinical trial data in case report forms (CRF’s) by abstracting data from source documents and carrying out query resolution. The coordination and monitoring of data is performed in accordance with the trial protocol, hospital and departmental guidelines and professional standards of practice. Data is assessed, compiled, recorded and submitted to cooperative groups and/or pharmaceutical companies or used for internal Princess Margaret studies. All data must be complete, accurate, timely and must be in compliance with applicable ICH-GCP, FDA and US federal code and Tri-Council regulations. The Clinical Study and Regulatory Specialist II must be able to interpret the applicable regulations in order to ensure compliance. Quality assurance procedures are utilized to ensure high quality data is obtained.

The Coordinator also undertakes study-related administrative tasks such as organizing meetings, taking minutes, obtaining signatures, and preparing submissions to and track approvals from the Research Ethics Board and Health Canada.

Duties

• Maintenance of Study regulatory submission
• Study documentation organization and filing within eTMF/eISF
• Study data entries via various EDCs and the use of EPIC
• At minimum, a completion of a Bachelor’s degree program, or recognized equivalent in Health or Science Related Discipline
• At least one to two (1-2) year experience in some or all of Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects
• Prior experience with EPIC and data coordinator role preferred
• Ability to understand and extract essential protocol information changes and summarize according to what is relevant to nursing and pharmacy teams
• Keen attention to detail especially with changes in drug doses and treatment regimen
• 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 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. At University Health Network (UHN), artificial intelligence technologies may be used to assist in the screening, assessment, and selection of candidates for this position.

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.