Clinical Study Regulatory Assistant

3 weeks ago

Toronto, Ontario, Canada University Health Network Full time

Job Summary

The University Health Network is seeking a highly organized and detail-oriented Clinical Study Regulatory Assistant to join its team. In this role, you will provide administrative and regulatory support to the clinical research staff of the Division of Medical Oncology and Hematology.

Key Responsibilities

  • Assist the clinical research team in performing study-specific tasks as per protocol
  • Responsible for data collection, entry, verification, and reporting
  • Enter medical data from health records or other sources into electronic data capture systems
  • Identify and log protocol and SOP deviations
  • Support the resolution of data queries from sponsors and issues query forms to the study team or third parties
  • Prepare submissions to the Research Ethics Board as needed
  • Execute study-related administrative tasks, such as collection and maintenance of regulatory documents
  • Maintenance and modification of study-specific trackers and study tools
  • Scheduling on-site/virtual monitoring visits and collecting necessary source documentation for data verification
  • Liaise between site and sponsor to ensure that all trial-related documentation and information are distributed to relevant staff involved with the trial
  • Ensure and maintain regulatory compliance for clinical research studies involving human subjects

Requirements

  • At minimum, a completion of a Bachelor's degree program in a Health or Science Related Discipline
  • At least one year of experience in Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects
  • 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 with 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

Why Work with Us?

The University Health Network is a leading healthcare provider and research institution in Canada. We offer a dynamic and inclusive work environment, competitive compensation packages, and opportunities for professional growth and development.

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