Clinical Study and Regulatory Specialist I

University Health Network • Toronto, ON

9d • CA$35 - CA$54 • Onsite

About The Position

The Clinical Study and Regulatory Specialist participates in the coordination of clinical trials from protocol review and regulatory approval through to activation, follow up and trial closure. This position is an 19-month term, temporary full-time contract, with the possibility of renewal for additional years, subject to performance, funding availability, and program requirements.

Requirements

• At minimum, a completion of a Bachelor’s degree program, or recognized equivalent in Health or Science-Related Discipline required
• At least two (2) year experience in some or all of Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects required
• 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

Nice To Haves

• Certification as a Clinical Research Professional, preferred

Responsibilities

• Preparation of Health Canada and Research Ethics Board submissions
• Monitoring and promoting the quality and integrity of data and recording clinical trial data in case report forms (CRFs). The coordination and monitoring of data is performed in accordance with the trial protocol, hospital and departmental guidelines and professional standards of practice.
• All data must be complete, accurate, timely, and must follow applicable ICH-GCP, FDA and US federal code and Tri-Council regulations.
• The Clinical Study and Regulatory Specialist I must be able to interpret the applicable regulations to ensure compliance. Quality assurance procedures are utilized to ensure high quality data is obtained.
• Executes study-related administrative tasks, such as maintenance and modification of study-specific trackers and study tools, collection and maintenance of regulatory documents, ethics submissions, protocols, staff training and delegation logs in paper and electronic formats

Benefits

• 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.)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level