Clinical Study Assistant II - AHRC - Clinical Trials Unit
St. Michael's Hospital
Toronto, Ontario, CA
2d 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 St.

Michael’s Hospital, 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 Study Assistant II is to support the Project Manager in performing various trial-related duties.

The role will involve general study administrative support, meeting coordination for internal meetings as well as external Investigator training meetings, maintenance of the study master file, preparing and distributing study supplies, tracking study progress, preparing and distributing study newsletters, reviewing study data and performing data validation activities (running validation reports, manual data review and issuing data queries), and communicating with the internal study team, study sponsor, vendors, and sites.

The successful applicant will work closely with investigators, study team members, study coordinators, sponsors and vendors.

The Clinical Study Assistant II will report to the Manager, Clinical Trials Unit (CTU) and must be flexible to work beyond the job description at times as work demands.

DUTIES & RESPONSIBILITIES :

  • Collecting and filing documents as per protocol, Standard Operating Procedures, guidelines and regulations.
  • Assisting in drafting and delivering relevant documents including REB documents for submission, Conflict of Interest (COI) disclosure statements, and regulatory documents
  • Managing / oversight of the study master file
  • Supporting the project team during electronic Case Report Form (eCRF) design / build and assisting in testing and validating the eCRF
  • Preparation and distribution of study newsletters on a regular basis
  • Administration / coordination of Investigator’s training meeting and other study meetings
  • Assisting with the completion of Health Canada CTA / CTA-A applications
  • Providing summary technical, operational, and scientific data and reporting (including productivity reports, metrics reports) to stakeholders (i.
  • e. funding agencies, government agencies, partners, and others) as well as to clients (academic researchers, academic research institutions, for-profit commercial entities, and more)

  • Generating reports for financial payments to research sites
  • Generate posters and conference abstracts on behalf of stakeholders, including performing basic descriptive statistical analyses of projects
  • Other duties as assigned
  • QUALIFICATIONS :

  • A BSc in a science or health-related discipline; postgraduate training in clinical trials management would be considered an asset
  • Training in ICH / GCP and / or CCRP accreditation would be an asset
  • Knowledge of medical / scientific terminology
  • Excellent organizational skills
  • Excellent communication skills
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