Clinical Study Regulatory Specialist I - UHN, Toronto

About this opportunity

Explore University Health Network careers and find healthcare jobs in Toronto that make a real difference. The Princess Margaret Cancer Centre is seeking a Clinical Study Regulatory Specialist I to join the Division of Medical Oncology and Hematology – Clinical Trials Group on a permanent full-time basis. In this role, you will participate in the coordination of clinical trials from protocol activation and follow up to trial closure.

Responsibilities

• 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 pharmaceutical companies or used for internal 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.
• Interpret the applicable regulations in order to ensure compliance. Quality assurance procedures are utilized to ensure high quality data is obtained.

What you'll bring

• At minimum, a Bachelor’s degree in a health or science-related discipline (required)
• Clinical Research Graduate Certificate (preferred)
• At least two (2) years experience in some or all of Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects
• At least one (1) year experience in the review and preparation of Health Canada and Research Ethics Board submissions, including writing informed consent forms
• 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 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

Compensation and perks

Working at uhn provides access to a comprehensive suite of benefits, programs, and perks designed to support you throughout your career.

• 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 including multiple corporate discounts on travel, restaurants, parking, phone plans, auto insurance discounts, and on-site gyms