Clinical Study Regulatory Assistant (Csra)

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.

Union: Non-Union
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
Grade: N0:03
Hours: 37.5 hours per week
Salary: $52,182 to $65,228 Annually (To commensurate with experience and consistent with UHN compensation policy)
Shifts: Monday - Friday
Status: Permanent Full Time
Closing Date: Until Filled

The Division of Medical Oncology and Hematology, University Health Network requires Clinical Research Study Assistant to work with its oncology and hematology clinical trial portfolio. This division runs a broad spectrum of therapeutic trials across all types of malignant disease. The Clinical Research Study Assistant will provide administrative and regulatory support to the clinical research staff of the DMOH Clinical Trials Group. Principle responsibilities include supporting the clinical research staff with preparation of the
submissions to the Research Ethics Board and Health Canada, maintenance of regulatory binders and study documentation, some data entry tasks, and other departmental administrative tasks. The Clinical Trials Group operates in accordance with the
trial protocol, hospital and departmental guidelines and professional standards of practice. Data is assessed, compiled, recorded and submitted to cooperative groups and/or pharmaceutical companies or used for internal PMH 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 Research Study Assistant 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.

Duties

• Assists the inter-professional clinical research team in performing study-specific tasks as per protocol
• Responsible for data collection, entry, verification and reporting
• Enters medical data from health records or other sources, as per approved study protocol and authorized access into electronic data capture (EDC) systems for example Redcap, Medidata, etc.
• Identifies and logs protocol and SOP deviations
• Supports resolution of data queries from sponsors and issues query forms to study team or third parties
• Supports the reporting of events to Research Ethics Board as needed(Privacy incidents and Serious Adverse Events (SAE))
• Prepares submissions (amendments, reportable events, annual renewals, study closures) to Research Ethics Board (REB)
• Executes study-related administrative tasks, such as collection and maintenance of regulatory documents, ethics submissions, protocols, staff training and delegation logs in paper and electronic formats
• Maintenance & modification of study-specific trackers and study tools (screening and enrollment worksheets, eligibility checklists)
• Scheduling on-site/virtual monitoring visits and collecting necessary source documentation for data verification
• Liaises between site and sponsor to ensure that all trial-related documentation and information are distributed to relevant staff involved with the trial
• Ensures and maintains regulatory compliance for clinical research studies involving human subjects by following appropriate protocols
• Coordinates the close-out phase of clinical study protocols as well as archival of study documents.

• At minimum, a completion of a Bachelor's degree program, or recognized equivalent in Health or Science Related Discipline (preferred)
• 3 to 6 months related experience is required
• At least one (1) year experience in some or all of Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects, an asset
• 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

Why join UHN?

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. It is the comprehensiveness of these offerings that makes it a differentiating factor, allowing you to find value where it matters most to you, now and throughout your career at UHN.

• Competitive offer packages
• Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP https://hoopp.com/)
• 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.)

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.

UHN uses email to communicate with selected candidates. Please ensure you check your email regularly.

Please be advised that a Criminal Record Check may be required of the successful candidate. Should it be determined that any information provided by a candidate be misleading, inaccurate or incorrect, UHN reserves the right to discontinue with the consideration of their application.

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.

We thank all applicants for their interest, however, only those selected for further consideration will be contacted.