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Clinical Study and Regulatory Assistant Intern

2 months ago

Toronto, Ontario, Canada University Health Network Full time

Job Title: Clinical Study and Regulatory Assistant Intern

Job Summary:

The University Health Network (UHN) is seeking a Clinical Study and Regulatory Assistant Intern to join our team. As a Clinical Study and Regulatory Assistant Intern, you will be responsible for supporting the Drug Development Program at Princess Margaret Hospital, which is the largest drug development program in Canada.

Key Responsibilities:

  • Scanning source documents and archiving clinical trial materials
  • Working closely with a multidisciplinary team across the Drug Development Program - Phase I (DDP1) and possibly, the Tumor Immunotherapy Program (TIP)
  • Assisting in coordinating clinical trials from startup to study activation, including data entry and query resolution
  • Executing study-related administration tasks, such as collection, scanning, organizing, and creation of regulatory documents
  • Tracking clinical trial materials
  • Drafting and submitting research ethics or institutional approval applications, such as amendments, renewals, and study closures to Research Ethics Board (REB)

Requirements:

  • Completion of a Bachelor's degree program, or recognized equivalent in Health or Science Related Discipline
  • Currently enrolled in a diploma, degree, or graduate certificate program at Seneca College, preferably the Clinical Research Program
  • Experience in drafting and submitting protocol and ICF amendments to REB preferred
  • Experience in adopting a country-specific ICF into an institutional ICF template preferred
  • Experience in initial trial submissions preferred
  • Proficiency with MS Office software
  • Understanding of some medical terminology
  • Knowledge of clinical research and of human research regulations and guidelines including ICH/GCP, Tri-Council Policy, Declaration of Helsinki, Health Canada TPD, and UHN policies
  • Excellent judgment, professionalism, tact, and diplomacy to work with diverse teams, all levels of leadership, and internal and external stakeholders
  • Strong communication, organizational, time management, and problem-solving skills
  • Ability to prioritize workload and work effectively under pressure
  • Ability to perform duties in a professional and courteous manner and produce high-quality work while meeting deadlines in accordance with UHN standards
  • Previous research experience is considered an asset

Why Work at UHN?

UHN is a caring, creative place where amazing people are amazing the world. As a Clinical Study and Regulatory Assistant Intern, you will have the opportunity to work with a talented and inspiring healthcare team, and contribute to the development of innovative drugs and immunotherapy.

What We Offer:

  • Competitive offer packages
  • Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP)
  • Close access to Transit and UHN shuttle service
  • A flexible work environment
  • Opportunities for development and promotions within a large organization
  • Additional perks (multiple corporate discounts including: travel, restaurants, parking, phone plans, auto insurance discounts, on-site gyms, etc.)

How to Apply:

Please submit your application through the UHN Careers portal. We thank all applicants for their interest, however, only those selected for further consideration will be contacted.