University Health Network
Clinical Study Startup Specialist-
This job is now closed
Job Description
- Req#: 929332
- Preparation of initial submissions to the Research Ethics Board and CAPCR system, set-up and maintenance of regulatory and study documentation, and liaising and negotiating with various internal and external stakeholders in accordance with ICH-GCP, FDA and US federal code, and Tri-Council regulations.
- Interpreting the applicable regulations and maintain regulatory compliance.
- Utilizing quality assurance procedures to ensure accuracy of regulatory materials submitted for review.
- Maintaining responsibility of study activation for a wide variety of research projects involving phase, I, II, and III trials sponsored by various pharmaceutical companies.
- Performing cross-functional and/or other duties, as assigned.
Qualifications
- At minimum, a completion of a Bachelor’s degree program, or recognized equivalent in Health or Science Related Discipline
- At least two (2) years of practical and related experience in some or all of oncology, clinical trials, medical terminology, regulatory issues involving human subjects
- At least 1 year of experience in data coordination of oncology clinical trials
- Excellent prioritization skills, excellent computer skills, ability to learn quickly and work independently
- Excellent interpersonal skills
- Ability to work under pressure and perform multiple concurrent tasks with a high level of 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
- 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 two (2) years of practical and related experience in some or all of oncology, clinical trials, medical terminology, regulatory issues involving human subjects
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- Interpreting the applicable regulations and maintain regulatory compliance.
Job Title: Clinical Study Startup Specialist
Job Posting: 929332
Union: Non-Union
Site: Princess Margaret Cancer Centre
Department: Division of Medical Oncology and Hematology, Department of Medicine
Reports to: Clinical Research Manager
Hours: 37.5 hours per week
Salary: $35.67 - $44.59 per hour: To Commensurate with experience and consistent with UHN compensation policy.
Status: Temporary Full-time (14 months)
Posted Date: March 1, 2024
Closing Date: March 30, 2024
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 Division of Medical Oncology and Hematology, University Health Network requires a Clinical Study Startup Specialist to work with its clinical trial portfolio across multiple disease sites.
The Clinical Study Startup Specialist participates in the pre-activation phase of a clinical trial from protocol review and approval through to activation.
Duties
- Preparation of initial submissions to the Research Ethics Board and CAPCR system, set-up and maintenance of regulatory and study documentation, and liaising and negotiating with various internal and external stakeholders in accordance with ICH-GCP, FDA and US federal code, and Tri-Council regulations.