Clinical Research Specialist II AHRC
St. Michael's Hospital
Toronto, Ontario, CA
23h ago

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 :

  • Plan and oversee all project management-related activities, including establishing project priorities, timelines, and milestones;
  • 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

  • Develop and distribute study-related documents, such as the master Informed Consent Form, study aids, and other study documents
  • Support site selection and site start-up activities
  • Coordinate development of the study eCRF and associated clinical data management documents
  • Coordinate study training materials and perform site training
  • Perform regulatory submissions to Health Canada, as required
  • Manage the study supplies; track incoming / outgoing study materials
  • Address complex protocol-related questions
  • Coordinate study-related meetings
  • Track study recruitment and other study milestones; develop the study recruitment plan
  • Coordinate and oversee data validation activities
  • Coordinate and / or perform some onsite clinical monitoring
  • Ensure conduct of research is carried out in accordance with ICH / GCP guidelines and applicable regulations, as well as SOPs
  • QUALIFICATIONS :

  • Bachelor’s Degree in a scientific discipline required, plus 3+ years of research-related experience
  • Master’s degree and / or CCRP certification and / or PMP certification is an asset
  • Ability to understand and interpret complex clinical study protocols
  • Strong leadership and project management skills, including strong organizational aptitude, ability to manage multiple responsibilities, and capacity to develop / meet challenging study timelines
  • Excellent written and verbal communication skills with ability to work both independently and in a team environment
  • Experience related to diabetes research, mobile healthcare app research and / or patient-oriented research would be an asset
  • Familiarity with ICH / GCP guidelines and the Canadian regulatory environment an asset
  • Experience working on research projects involving linkages with large healthcare administrative datasets (e.g. through ICES, CIHI) would also be an asset
  • Familiarity with models / theories and / or frameworks relevant to change management or implementation science an asset
  • Experience implementing workflow changes or related strategies in multidisciplinary health care contexts an asset
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