Clinical Study and Regulatory Specialist I

2 weeks ago

Toronto, Canada University Health Network Full time

**Job Posting#915682**

Position**: Clinical Study and Regulatory Specialist I**
Site: Princess Margaret Cancer Centre
Department: Clinical Trials Support Unit, Cancer Clinical Research Unit (CTSU)
Reports to: Clinical Research Manager
Salary Range: $62,771 - $78,468 per annum (Commensurate with experience and consistent with UHN Compensation Policy)
Hours: 37.5 hours per week
Status: Permanent Full-time

University Health Network (UHN) is looking for an experienced professional to fill the key role of **Clinical Study and Regulatory Specialist I** in our** Clinical Trials Support Unit (CTSU)** Department.

**_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 **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
- 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,

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