University Health Network
Clinical Study and Regulatory Specialist I
This job is now closed
Job Description
- Req#: 927190
- 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
- At least one (1) to two (2) years’ 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
Why join UHN?
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.
About the company
The University Health Network (UHN), consisting of Princess Margaret Cancer Centre, Toronto General Hospital, Toronto Western Hospital and Toronto Rehabilitation Institute, is a recognized leader in patient care, research and education. - At least one (1) to two (2) years’ experience in some or all of Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects
- The coordination and monitoring of data is performed in accordance with the trial protocol, hospital and departmental guidelines and professional standards of practice
JOB TITLE - Clinical Study and Regulatory Specialist I
Job Posting #: 927190
Union: NON-UNION
Site: Princess Margaret Cancer Centre
Department: Drug Development Program 2
Reports to: Clinical Research Manager
Hours: 37.5 hours per week
Salary: $64,974 - $81,218 annually. To commensurate with experience and consistent with UHN compensation policy
Status: Permanent Full-Time
Posted Date: December 7, 2023
Closing Date: Until Closed
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.
Position Summary
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.
Duties
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.