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About the Role

The Rheumatology Clinical Trials Unit at the Toronto Western Hospital/Schroeder Arthritis Institute is seeking a highly motivated individual to support the conduct and management of clinical trials, assist in facilitating and coordinating daily study activities, and play a critical role in the overall execution of the study.

Responsibilities

• Prepare, submit, and maintain Research Ethics Board (REB) applications, track ethics approvals, and regulatory submissions during and post study conduct.
• Prepare regulatory documents for REB submission.
• Prepare Investigator site file binders as per sponsor policies.
• Assist in study participant recruitment by identifying and screening potential subjects, obtaining informed consent, conducting pre-testing, and administering questionnaires or other data collection tools.
• Assist in data collection, source documentation and data entry following UHN policy and ICH/GCP guidelines.
• Identify problems using assessment skills and report any abnormalities to the Clinical Research Manager.
• Execute study-related administrative tasks, including the collection of regulatory documents and ethics submissions.
• Conduct telephone and/or clinical recruitment interviews.
• Perform various study-related tasks during study visits, such as basic administration, collecting, processing and shipping samples according to the trial protocol, archiving close-out studies, lab kit disposal and IP destruction.

Requirements

• Bachelor’s degree, or recognized equivalent, in a health or science-related discipline.
• At minimum, 1 to 2 years of related experience is required; clinical trial research experience is preferred.
• Understanding of ICH-GCP guidelines, TCPS2 standards, and Health Canada regulations.
• Experience with electronic data capture systems (Medidata Rave, Veeva Vault, RedCap) and skilled in query resolution and data quality assurance.
• Understanding of study protocols, case report forms (CRFs), and source documentation.
• Ability to coordinate with nurses, physicians, pharmacists, and study coordinators.
• Experience with lab techniques, sample handling, and safety protocols.
• Attention to detail and commitment to maintaining data integrity and confidentiality.
• Ability to work independently and collaboratively in a fast-paced environment.
• Ability to multi-task and perform in a fast-paced environment.
• Excellent interpersonal, verbal and written communication skills, required.
• Proficiency with MS Office software (Outlook, Word, Excel, PowerPoint).
• Excellent organizational and time management skills.
• Well-developed critical reasoning skills.
• 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.
• Current UHN employees must have successfully completed their probationary period, have a good employee record along with satisfactory attendance in accordance with UHN's attendance management program, to be eligible for consideration.
• All applications must be submitted before the posting close date.
• Please ensure you check your email regularly.
• A Criminal Record Check may be required of the successful candidate.
• Should it be કરવામાં that any information provided by a candidate be misleading, inaccurate or incorrect, UHN reserves the right to discontinue with the consideration of their application.

Skills

• ICH-GCP guidelines
• TCPS2 standards
• Health Canada regulations
• Medidata Rave
• Veeva Vault
• RedCap
• Query resolution
• Data quality assurance
• Lab techniques
• Sample handling
• Safety protocols
• MS Office software (Outlook, Word, Excel, PowerPoint)

Location

• Toronto Western Hospital

Work Type

• Temporary Full-time

Experience Level

• 1 to 2 years of related experience
• clinical trial research experience

Education Level

• Bachelor’s degree, or recognized equivalent, in a health or science-related discipline

Salary/Compensations

• CAD 33.80 - CAD 42.25 - hourly

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.)

About the Company

• UHN is Canada’s #1 hospital and the world’s #1 publicly funded hospital.
• With 10 sites and more than 44,000 TeamUHN members, UHN consists of Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute, The Michener Institute of Education and West Park Healthcare Centre.
• As Canada's top research hospital, the scope of biomedical research and complexity of cases at UHN have made it a national and international source for discovery, education and patient care.
• UHN has the largest hospital-based research program in Canada, with major research in neurosciences, cardiology, transplantation, oncology, surgical innovation, infectious diseases, genomic medicine and rehabilitation medicine.
• UHN is a research hospital affiliated with the University of Toronto.
• UHN’s vision is to build A Healthier World and it’s only because of the talented and dedicated people who work here that we are continually bringing that vision closer to reality.

Equal Opportunity

• UHN is an equal opportunity employer committed to an inclusive recruitment process and workplace.
• Requests for accommodation can be made at any stage of the recruitment process.
• Applicants need to make their requirements known.