Job Posting #:922205
JOB TITLE: Clinical Study & Regulatory Specialist I
Union: Non-Union
Site: Princess Margaret Cancer Centre
Department: Drug Development Program, Phase I
Reports to: Clinical Research Manager
Wage or Salary Range: $62,771 (minimum) per annum
Hours: 37.5 hours per week
Status: Permanent Full-time
Posted Date: October 5, 2023 (reposted)
Closing Date: Until Filled
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.
The Drug Development Program at Princess Margaret Hospital is the largest 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) for Early Phase Therapeutic studies. The Drug Development Program includes a Phase I program, focusing on studies of innovative drugs and immunotherapy, 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 Study and Regulatory Specialist I participates in the coordination of clinical trials from protocol review and approval through to activation, follow up and trial closure. Principal responsibilities include monitoring and promoting the quality and integrity of data and recording clinical trial data in case report forms (CRFs). 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, timely, and must follow applicable ICH-GCP, FDA and US federal code and Tri-Council regulations. The Clinical Study and Regulatory Specialist I must be able to interpret the applicable regulations to ensure compliance. Quality assurance procedures are utilized to ensure high quality data is obtained.
This role will work in a hybrid office environment – candidate will have the opportunity to work from home and will also have a workspace on site.
QUALIFICATIONS
- 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
- Working knowledge of CTCAE, electronic case report forms (eCRFs), REB submissions, and ICF amendments are assets
- 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
Post Date: July 4, 2023 Closing Date: Until filled
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.
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Competitive offer packages
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Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP https://hoopp.com/)
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Close access to Transit and UHN shuttle service
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A flexible work environment
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Opportunities for development and promotions within a large organization
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Additional perks (multiple corporate discounts including: travel, restaurants, parking, phone plans, auto insurance discounts, on-site gyms, etc.)
Current UHN employees must have successfully completed their probationary period, have a good employee record along with satisfactory attendance in accordance with UHN's attendance management program, to be eligible for consideration.
Vaccines (COVID and others) are a requirement of the job unless you have an exemption on a medical ground pursuant to the Ontario Human Rights Code.
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. Applicants need to make their requirements known in advance. Any information received related to an accommodation will be addressed confidentially.
University Health Network thanks all applicants, however, only those selected for an interview will be contacted.
