Organizational design for regulatory operations: staffing models by site size and study volume
Design a regulatory operations staffing model from quantitative workload data, evaluate centralized versus decentralized structures, and recognize how institutional context constrains the design space.
Organizational design for regulatory operations: staffing models by site size and study volume
Most regulatory functions at clinical research sites were never designed. They accreted. A site enrolled its first study, someone agreed to handle the IRB paperwork, the study list grew, the regulatory work grew with it, and at some point — usually after a missed continuing review or a frantic week reconstructing a delegation log — somebody asked the question that should have been asked years earlier: who is actually responsible for this?
I have spent enough years in clinical research to know that the most consequential failures of regulatory oversight are not, typically, failures of knowledge. They are failures of structure. A senior coordinator who knows GCP cold cannot enforce it across 40 active studies if the function reports to no one in particular, holds no budget authority, and has no escalation path when investigators decline a corrective action. The work in this lesson is to take that structural problem seriously — to treat the regulatory function as something a thoughtful person designed, on purpose, against a quantifiable workload, and not as something that simply happened.
What you will learn
By the end of this lesson, you will be able to: