Clinical Study Regulatory Assistant (CSRA)

The University Health Network, where “above all else the needs of patients come first”, encompasses Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute and the Michener Institute of Education. The breadth of research, the complexity of the cases treated, and the magnitude of its educational enterprise has made UHN a national and international resource for patient care, research and education. With a long tradition of ground-breaking firsts and a purpose of “Transforming lives and communities through excellence in care, discovery and learning”, the University Health Network (UHN), Canada’s largest research teaching hospital, brings together over 16,000 employees, more than 1,200 physicians, 8,000+ students, and many volunteers. UHN is a caring, creative place where amazing people are amazing the world.

Union: Non-Union
Site: Princess Margaret Cancer Centre
Department: Division of Medical Oncology and Hematology - Clinical Trials Group
Reports to: Clinical Research Manager, DMOH-CTG
Work Model: On-Site
Grade: N0:03
Hours: 37.5 hours per week
Salary: $50,669 to $63,336 annually: To commensurate with experience and consistent with UHN compensation policy
Shifts: Monday - Friday
Status: Permanent Full Time
Closing Date: July 31, 2024

The Division of Medical Oncology and Hematology, University Health Network requires Clinical Research Study Assistant to work with its oncology and hematology clinical trial portfolio. This division runs a broad spectrum of therapeutic trials across all types of malignant disease. The Clinical Research Study Assistant will provide administrative and regulatory support to the clinical research staff of the DMOH Clinical Trials Group. Principle responsibilities include supporting the clinical research staff with preparation of the
submissions to the Research Ethics Board and Health Canada, maintenance of regulatory binders and study documentation, some data entry tasks, and other departmental administrative tasks. The Clinical Trials Group operates 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 PMH 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 Research Study Assistant 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.

Duties

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.

All UHN Employees are required to be fully vaccinated with a COVID-19 vaccine series, approved by Health Canada or the World Health Organization, as a condition of hire. Proof of COVID-19 vaccination will be required. Should you be the successful candidate, you will be required to comply with UHN’s mandatory Vaccination Policy that is in effect.

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.

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.

All UHN Employees are required to be fully vaccinated with a COVID-19 vaccine series, approved by Health Canada or the World Health Organization, as a condition of hire. Proof of COVID-19 vaccination will be required. Should you be the successful candidate, you will be required to comply with UHN’s mandatory Vaccination Policy that is in effect.

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.