Clinical Trials IWRS Monitor

2 months ago

Markham, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Title: Clinical Trials IWRS Monitor

Everest Clinical Research Services Inc is seeking a highly skilled and detail-oriented Clinical Trials IWRS Monitor to join our team. As a key member of our clinical research team, you will be responsible for ensuring the accuracy and quality of data generated within our IWRS/IRT and eDiary systems.

Key Responsibilities:
  • Act as primary contact with CTT Users for the Everest IWRS/IRT and eDiary team via the CTT Helpdesk telephone or IWRS helpdesk email accounts.
  • Support client requests and issue analysis, problem solving, and resolution, working closely with CTT Developers and internal Everest Data Management and Statistical & Programming teams.
  • Monitor data generated within CTT applications to ensure accuracy and quality.
  • Coordinate and verify changes to the database and application using appropriate change control procedures.
  • Act as off-hours escalation point for junior IWRS Clinical Monitor resources or the outsourced call centre service to resolve high urgency client requests.
  • Generate, maintain, and/or review CTT Requirements Specification documents.
  • Execute CTT application test planning, test plan, and test script development and Stage I and II testing activities for CTT applications.
  • Generate, maintain, and/or review Quick Reference Guides for all CTT studies.
  • Conduct CTT demonstrations to sponsors as well as training demonstrations to study team members.
  • Support communications and coordination with Sponsors, Study Team Members, Depot personnel and internal Everest data management and statistical leads across the IWRS development lifecycle.
  • Cooperate with and assist, when required, data management quality assurance (QA) personnel in performing QA procedures on CTT applications.
  • Analyze CTT monitoring and support trends to identify new CTT core features that will improve efficiency, effectiveness, user satisfaction and market competitiveness.
Qualifications and Experience:
  • A Bachelor's degree in health science, physical or biological fields with at least 3 years' experience in clinical trial data processing and management.
  • Education or experience must demonstrate the ability to work independently, to have a clear, professional and energetic telephone voice, and detailed approach to data review and system development.

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