Find out about our purpose, values and principles here.The Clinical Trial Support Unit (CTSU), University Health Network is looking for a Clinical Study and Regulatory Specialist I to work with its oncology and hematology clinical trial portfolio. The CTSU runs a broad spectrum of therapeutic trials across all types of malignant disease. The CTSU is part of the Cancer Clinical Research Unit (CCRU) which provides various learning opportunities via its Education and Quality Assurance Program.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 research ethics board submissions, regulatory file maintenance, monitoring and promoting the quality and integrity of data and recording clinical trial data in case report forms (CRF’s) by abstracting data from source documents and carrying out query resolution,. 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 Princess Margaret studies. All data must be complete, accurate, timely and must be in compliance with 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 in order to ensure compliance. Quality assurance procedures are utilized to ensure high quality data is obtained.
The Coordinator also undertakes study-related administrative tasks such as organizing meetings, taking minutes, obtaining signatures, and preparing submissions to and track approvals from the Research Ethics Board and Health Canada.
QUALIFICATIONS:- At minimum, a completion of a Bachelor’s degree program, or recognized equivalent in Health or Science-Related Discipline
- Certification as a Clinical Research Professional, preferred
- At least one (1) to two (2) year experience in some or all of Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects
- Experience using statistical analysis and data management software applications, preferred
- Previous experience with regulatory/ethics submissions, preferred
- 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
Vaccines (COVID-19 and others) are a requirement of the job unless you have an exemption on a medical ground pursuant to the Ontario Human Rights Code 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: March 5, 2023 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. UHN is a respectful, caring, and inclusive workplace. We are committed to championing accessibility, diversity and equal opportunity and welcomes all applicants including but not limited to: all religions and ethnicities, LGBTQ2s+, BIPOC, persons with disabilities and all others who may contribute to the further diversification of ideas. Requests for accommodation can be made at any stage of the recruitment process providing the applicant has met the Bona-fide requirements for the open position. Applicants need to make their requirements known when contacted
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.
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