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Empowering Clinical Research Through New Operational Roles at the Site Level

This session proposes a new operational paradigm focused on redesigning the internal structure of clinical trial sites through the incorporation of specialized roles--with active support from the industry--to ensure quality, efficiency, and long-term sustainability. The presenter will analyze the structural limitations of the traditional site model and their implications for quality, compliance, and efficiency; demonstrate the strategic value of new key roles such as clinical trial managers, quality control specialists, quality assurance specialists, clinical trial educators, and clinical research coordinator assistants; present a scalable framework based on quality management systems (QMS) that integrates these roles; and offer an action plan to transform site structures and strengthen the workforce.

CEU: 1.00 ACRP

Speaker:

Earlier Event: April 26
From Silos to Synergy: Fixing Budget Friction Through Cross-Stakeholder Understanding
Later Event: April 26
Budget Justice: Standardizing Principles and Customizing Site Needs