Clinical Study

2 weeks ago

Toronto, Canada University Health Network Full time

Position: Clinical Study & Regulatory Specialist I x2 Positions

Job Posting Number: 922391
Site: Princess Margaret Cancer Centre
Department: Drug Development Program
Reports to: Clinical Research Manager
Salary Range: $62,771 - $78,468 per annum (Commensurate with experience and consistent with 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 Study & Regulatory Specialist I.

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 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.

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). The Drug Development Program includes a Phase II program, focusing on studies across the various phases of trials with a strong emphasis on pharmacokinetics, translational studies and Investigator Initiated Trials. It involves a collaborative and multidisciplinary approach and is strategically designed to ensure the rapid completion of high quality studies.

The Clinical Study and Regulatory Specialist I leads study and regulatory coordination from activation to close-out of Phase I, II, II clinical studies. Principal responsibilities include abstracting data from source documents, performing data entry into electronic case report forms, monitoring of data and preparing submissions to Health Canada and Research Ethics Board. 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. Quality assurance procedures are utilized to ensure high quality data is obtained. The Clinical Study and Regulatory Specialist must be able to interpret the applicable regulations in order to ensure compliance and is also responsible for study-related administrative tasks.

QUALIFICATIONS
- At minimum, a completion of a Bachelor’s degree program, or recognized equivalent in Health or Science Related Discipline
- 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

Vaccines (COVID-19 and others) are a requiremen

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