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Clinical Study and Regulatory Specialist
3 months ago
**JOB POSTING # (916745)**
Position**: Clinical Study and Regulatory Specialist I**
Site: Princess Margaret Cancer Centre
Department**:Drug Development Program, Phase I**
Reports to: Clinical Research Manager
Salary Range**:$62,771 -** $**78,468 per year** per annum (Commensurate with experience and consistent with the UHN Compensation Policy)
Hours**:37.5HRS / week; 9:00-5:00; Monday to Friday**
Status: Permanent Full-Time (Hybrid)
**University Health Network (UHN) **is looking for an experienced professional to fill the key role of** Clinical Study and Regulatory Specialist I** in our Drug Development Program, Phase 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 groundbreaking 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 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 Drug Development Program - Phase I requires a Clinical Study and Regulatory Specialist I** to work within its external operations oncology clinical trials portfolio. This division coordinates the regulatory start-up of phase I-III drug trials across all types of malignant diseases. The Clinical Study and Regulatory Specialist I will work closely under the direction of the Supervisor and Clinical Research Manager (CRM) to coordinate the successful trial start-up activities of the department.
Principal responsibilities include overseeing and participating in the start-up of oncology studies from protocol review through to local activation. These functions will be carried out while performing the functions of a regulatory coordinator on trials as assigned by the CRM, which includes submission locally to the research ethics board and Health Canada. Responsibilities also include, but are not limited to, preparation of initial submissions to the 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; performing cross-functional and/or other duties, as assigned.
- This role will work in a remote environment_.
**QUALIFICATIONS**:
- At minimum, a completion of a Bachelor’s degree program, or recognized equivalent in Health or Science Related Discipline
- Working knowledge of REB submissions, Health Canada Submissions and ICF Amendments
- 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 meet
