Clinical Study and Regulatory Specialist I

4 weeks ago

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

At the University Health Network, we are seeking a highly skilled Clinical Study and Regulatory Specialist I to join our team. This role will be responsible for coordinating 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, excellent 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 Us?

At the University Health Network, we offer a comprehensive benefits package, competitive salary, and opportunities for professional growth and development. We are committed to creating a diverse and inclusive work environment that values and respects the contributions of all employees.

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