Clinical Study and Regulatory Specialist I

2 weeks ago

Toronto, Ontario, Canada University Health Network Full time

JOB POSTING # 917267

Position:
Clinical Study and Regulatory Specialist I

Site:
Princess Margaret Cancer Centre

Department:
Tumor Immunotherapy Program

Reports to:
Clinical Research Manager

Salary Range:
$62,771 per year to $78,468 per year per annum (Commensurate with experience and consistent with the UHN Compensation Policy)

Hours: 37.5hrs/week, Monday to Friday, 9am to 5pm

Status:
Permanent Full-Time (Hybrid)

Number of Openings: 2

University Health Network (UHN) is looking for an experienced professional to fill the key role of
Clinical Study and Regulatory Specialist I in our
Tumor Immunotherapy Program (TIP)

  • 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 Tumor Immunotherapy Program at Princess Margaret Cancer Centre is the first program of its kind in Canada and one of only a handful of others around the world.

The program brings together specialists in the fields of immunology, oncology, pathology and surgery who have expertise spanning from basic immunology discoveries through clinical trials of immune therapies.

The Tumor Immunotherapy Program is focused on improving our knowledge of the immune system to better diagnose, detect and target cancers.


The Clinical Data Coordinator (Clinical Study Coordinator) participates in the coordination of clinical trials from protocol review and regulatory approval through to activation, follow up and trial closure.

Principal responsibilities include preparation of Health Canada and Research Ethics Board submissions, abstracting data from source documents, performing data entry into electronic case report forms (eCRF's), query resolution, monitoring and promoting the quality and integrity of data.

The coordination and monitoring of data is performed in accordance with the trial protocol, hospital and departmental guidelines and professional standards of practice.

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.

This individual 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
  • At least one (1) year experience in the review and preparation of Health Canada and Research Ethics Board submissions, including writing informed consent forms
  • 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 diversit

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