University Health Network (UHN) is looking for an experienced professional to fill the key role of Clinical Data Coordinator in our Drug Development Program II.
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 Drug Development Program at Princess Margaret Cancer Centre is the largest new drug development program in Canada and the only centre outside of the United States to have a contract with the National Institutes of Health (NIH). It is an exciting initiative focusing on phase I II and III studies of innovative drugs with a strong emphasis on pharmacokinetics and correlative studies. It involves a collaborative and multidisciplinary approach and is strategically designed to ensure the rapid completion of high quality studies.
The Clinical Data Coordinator participates in the coordination of clinical trials from protocol review and approval through to activation, follow up and trial closure. Principal responsibilities include 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 PMH studies. All data must be complete, accurate, and timely and must be in compliance with applicable ICH-GCP, FDA and US federal code and Tri-Council regulations. The coordinator may provide study initiation support to the Clinical Research Managers (as Start-up Coordinator), such as preparation of Initial submission to REB & CAPCR, liaising & negotiating with internal and external stakeholders, support managers in expediting lauch of new clinical trials across studies. The Clinical Data 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 some or all of Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects
- Some experience with Health Canada regulatory submissions and site management
- 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 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
- Satisfactory attendance
- Certification as a Clinical Research Professional, preferred
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.
POSTED DATE: September 17, 2020 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.
University Health Network has a diverse workforce and is an equal opportunity employer.