Clinical Study and Regulatory Specialist I

UHN is Canada’s #1 hospital and the world’s #1 publicly funded hospital. With 10 sites and more than 44,000 TeamUHN members, UHN consists of Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute, The Michener Institute of Education and West Park Healthcare Centre. As Canada's top research hospital, the scope of biomedical research and complexity of cases at UHN have made it a national and international source for discovery, education and patient care. UHN has the largest hospital-based research program in Canada, with major research in neurosciences, cardiology, transplantation, oncology, surgical innovation, infectious diseases, genomic medicine and rehabilitation medicine. UHN is a research hospital affiliated with the University of Toronto.

UHN’s vision is to build A Healthier World and it’s only because of the talented and dedicated people who work here that we are continually bringing that vision closer to reality.

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Position Summary:
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:

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.