Job Description

Company DescriptionThe University Health Network, where \xe2\x80\x9cabove all else the needs of patients come first\xe2\x80\x9d, 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 \xe2\x80\x9cTransforming lives and communities through excellence in care, discovery and learning\xe2\x80\x9d, 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: Toronto General Hospital
Department: Toronto General Hospital Clinical Research Unit
Reports to: Clinical Research Manager
Work Model: Hybrid
Grade: D0:07
Hours: 37.5 hours per week
Salary: $38.02- $47.53 per hour.
Shifts: Monday to Friday
Status: Permanent Full Time
Closing Date: August 19, 2024Position Summary
The Toronto General Hospital Clinical Research Unit (TGH CRU) is a newly established program that aims to assist staff with the conduct and operationalization of clinical research studies. Working under the direction of the Clinical Research Manager with oversight from the site Medical Lead, the Clinical Research Coordinator II (CRC II) will work on a variety of projects across numerous disease sites within TGH. More specifically, the CRC II will utilize their clinical research experience to support various investigators to complete tasks pertaining to study start-up and coordination, budget development and management, and study monitoring and auditing. The CRC II will also have the opportunity to work collaboratively with the CRU manager on initiatives that span different sites at UHN.Duties
Duties of the CRC II include but are not limited to the following:

• Recruitment of study participants (e.g., identifies and screens potential subjects; obtains informed consent; administers questionnaires or other data collection tools)
• Plans, implements, reviews and coordinates all aspects of data collection and source documentation (including adverse events and sample processing and shipping), as per UHN policy and ICH/GCP guidelines
• Prepares submissions to the Research Ethics Board and Coordinated Approval Process for Clinical Research (CAPCR) and maintains appropriate documentation
• Prepares submissions to external parties (e.g., CTO, OCREB, etc.)
• Liaises with investigators and sponsors for monitoring/audits and leads internal quality assurance activities
• Reviews contracts and prepares documentation for internal/external reporting
• Reviews clinical trial protocols for budget development (i.e., assessing needs for study tasks, staffing, and internal/external services costs)
• Develops and negotiates budgets for clinical research studies, monitors internal cost recoveries, and provides financial oversight (i.e., ensuring alignment between study protocol, budget, and contracts)

Qualifications

• At minimum, Bachelor\'s degree, or recognized equivalent, in a health or science-related discipline, Master\'s degree preferred
• Holds recognized certification in clinical research (e.g., ACRP or SOCRA) or equivalent
• Between 3-5 years of clinical research experience in a hospital setting coordinating both investigator-initiated and industry-sponsored clinical trials
• Between 3-5 years of experience preparing and managing clinical trial budgets for investigator-initiated and/or industry-sponsored clinical trials
• Between 3-5 years of experience in providing support for monitoring/audits and regulatory inspections
• Knowledge of research regulations and guidelines, such as ICH/GCP guidelines, Tri-Council Policy, Declaration of Helsinki and FDA CFR and Health Canada TPD
• Highly motivated and self-directed individual who works well under pressure and with minimal direction
• Demonstrates excellent written, verbal, and interpersonal communication skills, adept at prioritizing projects with competing deadlines, highly skilled at adapting to meet the changing needs of stakeholders and thrives in a fast-paced environment
• Knowledge of applicable legislative, UHN and/or departmental policies

Additional InformationWhy 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

) * 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.

University Health Network