Job Posting #879427 Re-Post: if you have already applied to this position, please do not re-apply
Position: Clinical Research Data & Regulatory Coordinator (4 Positions)
Site: Princess Margaret Cancer Centre
Department: Clinical Trial Support Unit, Cancer Clinical Research Unit
Reports to: Manager, Clinical Trials Support Unit
Pay Scale: $56,737.00 - $70,922.00 per annum (Commensurate with experience and consistent with the UHN compensation policy)
Hours: 37.5 hours per week
Status: Permanent Full Time
University Health Network (UHN) is looking for an experienced professional to fill the key role of Clinical Research Data & Regulatory Coordinator in our Clinical Trials Support Unit.
Transforming lives and communities through excellence in care, discovery and learning.
The University Health Network, where “above all else the needs of patients come first”, encompasses Toronto Rehabilitation Institute, Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre and the Michener Institute of Education at UHN. 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 groundbreaking 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.
University Health Network (UHN) is a research hospital affiliated with the University of Toronto and a member of the Toronto Academic Health Science Network. The scope of research and complexity of cases at UHN have made it a national and international source for discovery, education and patient care. Research across UHN's five research institutes spans the full spectrum of diseases and disciplines, including cancer, cardiovascular sciences, transplantation, neural and sensory sciences, musculoskeletal health, rehabilitation sciences, and community and population health. Find out about our purpose, values and principles here.
The Clinical Trial Support Unit (CTSU), University Health Network is looking for a Clinical Research Data and Regulatory Coordinator to work with its 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 Research Data and Regulatory Coordinator 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). 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 Research Data and Regulatory Coordinator 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.
At minimum, a completion of a Bachelor’s degree program, or recognized equivalent in Health or Science Related Discipline
At least two (2) year experience in Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects
Demonstrated relevant clinical research knowledge
Excellent written and verbal communication skills, excellent organization, prioritization skills, good computer skills, ability ty 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 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
Certification as a Clinical Research Professional, preferred
Vaccines (COVID-19 and others) are a requirement of the job unless you have an exemption on a medical ground pursuant to the Ontario Human Rights Code.
If you are interested in making your contribution at UHN, please apply on-line. You will be asked to copy and paste as well as attach your resume and covering letter. You will also be required to complete some initial screening questions.
Closing Date: Until Filled
For current UHN employees, only those who have successfully completed their probationary period, have a good employee record along with satisfactory attendance in accordance with UHN's attendance management program, and possess all the required experience and qualifications should apply.
University Health Network thanks all applicants, however, only those selected for an interview will be contacted.
UHN is a respectful, caring, and inclusive workplace. We are committed to championing accessibility, diversity and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process providing the applicant has met the Bona-fide requirements for the open position. Applicants need to make their requirements known when contacted.