Clinical Study

2 weeks ago

Toronto, Ontario, Canada University Health Network Full time $64,974 - $81,218

The University Health Network, where "above all else the needs of patients come first", encompasses Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute and the Michener Institute of Education.

The breadth of research, the complexity of the cases treated, and the magnitude of its educational enterprise has made UHN a national and international resource for patient care, research and education.

With a long tradition of ground-breaking firsts and a purpose of "Transforming lives and communities through excellence in care, discovery and learning", the University Health Network (UHN), Canada's largest research teaching hospital, brings together over 16,000 employees, more than 1,200 physicians, 8,000+ students, and many volunteers.

UHN is a caring, creative place where amazing people are amazing the world.

Site:
Princess Margaret Cancer Centre

Department:
Division of Medical Oncology and Hematology - Clinical Trials Group

Reports to:
Clinical Research Manager, DMOH-CTG

Work Model:
On-Site

To commensurate with experience and consistent with UHN compensation policy

Shifts:
Monday - Friday
Permanent Full Time

The Clinical Study and Regulatory Specialist I participates in the coordination of clinical trials from protocol activation and follow up to trial closure.

Principal responsibilities include 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.

The Clinical Study and Regulatory Specialist I must be able to interpret the applicable regulations in order to ensure compliance.

Quality assurance procedures are utilized to ensure high quality data is obtained.

At minimum, a completion of a Bachelor's degree program, or recognized equivalent in Health or Science-Related Discipline
At least two (2) year 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
Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance to UHN standards
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
Certification as a Clinical Research Professional, preferred

In addition to working alongside some of the most talented and inspiring healthcare professionals in the world, UHN offers a wide range of benefits, programs and perks.

Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP
) * A flexible work environment
Additional perks (multiple corporate discounts including: travel, restaurants, parking, phone plans, auto insurance discounts, on-site gyms, etc.)

All UHN Employees are required to be fully vaccinated with a COVID-19 vaccine series, approved by Health Canada or the World Health Organization, as a condition of hire.

Proof of COVID-19 vaccination will be required.

Should you be the successful candidate, you will be required to comply with UHN's mandatory Vaccination Policy that is in effect.

Requests for accommodation can be made at any stage of the recruitment process.

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