Clinical Study and Regulatory Specialist I

1 week ago

Toronto, Ontario, Canada University Health Network Full time
Job Title: Clinical Study and Regulatory Specialist I

University Health Network (UHN) is seeking a highly skilled Clinical Study and Regulatory Specialist I to join our team. As a key member of our Cancer Genomics Program, you will play a critical role in the coordination of clinical trials from protocol review and regulatory approval through to activation, follow-up, and trial closure.

Key Responsibilities:
  • Research Ethics Board submissions, study document creation/review, consent form collection rounds, clinical data abstraction from medical charts and other source documents into electronic case report forms (eCRFs), and query resolution.
  • Coordination of data abstraction in accordance with the study protocol, hospital, and departmental guidelines, and professional standards of practice.
  • Ensuring all data is completed accurately and on time, and in compliance with applicable ICH-GCP, Tri-Council, and federal regulations.
  • Interpreting applicable regulations to ensure compliance.
  • Quality assurance procedures to ensure high-quality data is obtained.
  • Study-related administrative tasks such as organizing meetings, taking minutes, and obtaining signatures.
Requirements:
  • Minimum of a Bachelor's degree in a Health or Science-Related Discipline.
  • At least two years of experience in oncology, clinical trials, medical terminology, and regulatory issues involving human subjects.
  • At least one year of experience in the review and preparation of Research Ethics Board submissions.
  • Demonstrated relevant clinical research knowledge.
  • High proficiency in Microsoft Excel.
  • Excellent written and verbal communication skills, organization, prioritization skills, computer skills, ability to learn quickly, and work independently.
  • Excellent interpersonal skills.
  • Ability to work under pressure and attend to details.
  • 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.
  • Satisfactory attendance.
  • Certification as a Clinical Research Professional is preferred.
Why Join UHN?

At UHN, we offer a comprehensive benefits package, opportunities for development and promotions within a large organization, and a flexible work environment. We are committed to an inclusive recruitment process and workplace. Requests for accommodation can be made at any stage of the recruitment process. Applicants need to make their requirements known.

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