The Applied Health Research Centre (AHRC) of the Li Ka Shing Knowledge Institute is an Academic Research Organization (ARO) that provides clinical study project coordination and data management services to Investigators and sponsors at the University of Toronto, and beyond.
The AHRC supports and manages all aspects of the clinical trials process including protocol development, study document development, clinical site management, clinical data management, data analysis and report writing.
This position will offer the successful applicant a challenging and rewarding career in the clinical research area.
The primary role of the Clinical Research Specialist II will be to manage and coordinate assigned multi-site clinical trials, working closely with the sponsor, vendors and the internal AHRC team.
The CRS II will be responsible for meeting study milestones on time and within budget. Duties may involve writing study protocols and research reports, site selection, site management, training of internal and external staff, overseeing and / or performing study monitoring / QA activities, leading the development of the eCRF and study database, overseeing data validation activities and responding to issues, preparing study documents, managing study meeting coordination, tracking study progress, tracking the study budget, internal and external study audits, communicating with the internal study team as well as the study sponsor, vendors, academic partners, and sites, and ensuring that issues are resolved in a timely manner.
For this position, we are seeking a Clinical Research Specialist II to lead the project management of an exciting new pragmatic clinical trial which will test an innovative mobile health system intervention to help patients with Type 1 Diabetes achieve better diabetes control in a way that places less burden on individuals and is more patient-oriented.
Specifically, the intervention will involve electronic delivery of health care and related support services (including virtual visits and web-based resources) in addition to usual care.
Study health outcomes will include diabetes control (A1c), patient-reported experiences and outcomes, and heath care use and costs.
DUTIES & RESPONSIBILITIES :
proactively working with team members to move the project forward in a timely manner; and liaising with research team members, study staff, clinical sites, and other stakeholders to ensure the success of the project