Clinical Data and Regulatory Coordinator

1 month ago

Toronto, Ontario, Canada University Health Network Full time
Company Description

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.

Job Description

Union: Non-Union
Site: Toronto Western Hospital
Department: Rheumatology
Reports to: Principal Investigator
Work Model: On-Site
Grade: N0:05
Hours: 37.5 hours per week
Salary: $ $38.40 per hour
Status: Temporary Full-time (1 year contract, with possibility for extension)
Closing Date: August 23, 2024

Position Summary
The Rheumatology Clinical Trials Unit at the Toronto Western Hospital/Schroeder Arthritis Institute is seeking a highly motivated individual to join our team. We are a busy clinical trial unit with a focus on Systemic Lupus Erythematosus, Psoriatic Arthritis, Osteoarthritis, Rheumatoid Arthritis and Sjogren's Syndrome trials. Working under supervision of multiple principal investigators, the Clinical Data and Regulatory Coordinator will assist in conduct, and management of clinical trials. The CDRC will assist in facilitating and coordinating daily clinical trial activities and plays a critical role in the conduct of the study.

Duties
Working under the directions of the Director of the Rheumatology Clinical Trial Unit, Clinical Research Manager and other senior research staff members the Clinical Data and Regulatory Coordinator's (CDRC) responsibilities include but are not limited to:

  • Prepare, submit, and maintain Research Ethics Board (REB) applications, track ethics approvals, and regulatory submissions during and post study conduct, including but not limited to, SAEs, End of Study Notifications, Amendments, Renewals, responses to other submissions queries/questions/observations, etc.
  • 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 and source documentation 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
Qualifications
  • Bachelors Degree or recognized equivalent, in health related field or science-related discipline.
  • Minimum three (3) months of related experience; clinical research experience preferred.
  • Knowledgeable with ICH-GCP guidelines.
  • Experience handling and processing biospecimen samples preferred.
  • Ability to work under pressure and attention to detail.
  • Ability to multi-task & 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.
Additional Information

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 )
  • 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.

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.

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.

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.

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