Clinical Data & Regulatory Coordinator
Princess Margaret Cancer Centre
Toronto, Ontario, CA
3d ago

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 Division of Medical Oncology and Hematology, University Health Network requires a Clinical Data & Regulatory Coordinator to work with its clinical trial portfolio across multiple disease sites.

The Clinical Data & Regulatory Coordinator 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, recording clinical trial data in case report forms (CRFs), and compilation of ethics and regulatory documents.

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 be in compliance with applicable ICH-GCP, FDA and US federal code and Tri-Council regulations.

The Clinical Data Coordinator 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.

QUALIFICATIONS

  • At minimum, a completion of a Bachelor’s degree program, or recognized equivalent in Health or Science Related Discipline
  • At least two (2) years experience in Oncology and / or Clinical trials. Demonstrated relevant clinical research knowledge, previous experience in hematological and / or solid tumor disease sites is an asset
  • 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 with 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
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