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Clinical Research Study Assistant

6 months ago

Toronto, Canada University Health Network Full time

Position: Clinical Research Study Assistant x3 Positions

Job Posting Number: 922401
Site: Princess Margaret Cancer Centre
Department: Drug Development Program
Reports to: Clinical Research Manager
Salary Range: $48,945 - $61,191 per annum (Commensurate with experience and consistent with UHN Compensation Policy)
Hours: 37.5 hours per week
Status: Permanent Full-time

University Health Network (UHN) is looking for an experienced professional to fill the key role of Clinical Research Study Assistant.

Transforming lives and communities through excellence in care, discovery and learning.

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

University Health Network (UHN) is a research hospital affiliated with the University of Toronto and a member of the Toronto Academic Health Science Network. The scope of research and complexity of cases at UHN have made it a national and international source for discovery, education and patient care. Research across UHN's five research institutes spans the full spectrum of diseases and disciplines, including cancer, cardiovascular sciences, transplantation, neural and sensory sciences, musculoskeletal health, rehabilitation sciences, and community and population health. Find out about our purpose, values and principles here.

The Drug Development Program at Princess Margaret Cancer Centre is the largest new drug development program in Canada and the only center outside of the United States to have a contract with the National Institutes of Health (NIH). The Drug Development Program includes a Phase II program, focusing on studies across the various phases of trials with a strong emphasis on pharmacokinetics, translational studies and Investigator Initiated Trials. It involves a collaborative and multidisciplinary approach and is strategically designed to ensure the rapid completion of high quality studies.

The Clinical Study and Regulatory Assistant provides assistance to study team in preparing environment for conducting research activities as per protocol. Follows established procedures, guidelines and complies with applicable regulations. Performs data transcription from health records or other sources, as per approved study protocol, assists with collecting and redacting source. Helps with study start-up activities such as completing 1572, financial disclosure forms, etc. Assists with study close out activities including filing and sorting through source documentation. May assist in the preparation of submissions to the Research Ethics Board. Assists Study coordinators by obtaining signatures, maintaining study trackers, collecting CVs, Medical Licenses & Training documents. Performs administrative functions such as room bookings, supply ordering, maintaining timesheets, lab licenses, administrative binders. Provides assistance with the maintenance & modification of electronic & paper information filing/retrieval methods, systems and/or formats

QUALIFICATIONS
- At a minimum Community college diploma in a health related discipline, or equivalent required
- Minimum 3 to 6 months clinical research related experience
- Demonstrated relevant knowledge of clinical research and of human research regulations and guidelines of applicable legislative, UHN and/or departmental policies.
- Certification as a Clinical Research Professional, preferred
- Knowledge of Research regulations and guidelines (such as ICH/GCP, Tri-Council Policy, Declaration of Helsinki, FDR, CFR and Health Canada TPD as required)
- Excellent written and verbal communication skills, excellent organization, prioritization skills, good computer skills, ability to learn quickly and work independently
- Ability to work under pressure, strong attention to detail, ability to perform multiple concurrent tasks
- Proficiency with MS Office software
- Adheres to confidentiality policy for sensitive patient data and information
- Excellent interpersonal skills
- 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