Regulatory Coordinator
Full course · Regulatory Submissions & Stakeholder Management
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Teaches the regulatory coordinator to conduct a submission landscape assessment, cataloguing every active study, its IRB, its deadlines, and its current regulatory status to make the aggregate workload visible.
Here is something I have observed consistently across sites of every size: the aggregate regulatory submission workload is almost always invisible to the people responsible for managing it. Each coordinator knows their own studies' deadlines. The principal investigator has a vague sense that "things are busy." The department administrator sees invoiced IRB fees but has no idea what they represent operationally. And the regulatory coordinator -- the person who should have the clearest view of the entire landscape -- often starts the job with no systematic way to see it.
This invisibility is not a minor inconvenience. It is the root cause of the failure modes described in the previous lesson. You cannot manage deadline collisions you cannot see. You cannot allocate resources against workload peaks you have not measured. You cannot build a pipeline for a landscape you have not mapped.
This lesson teaches you to make the invisible visible. Before you build tracking systems (Lesson 3) or quality control processes (Lesson 4), you must first conduct a submission landscape assessment -- a systematic inventory of every active study, its IRB of record, its submission history, its upcoming deadlines, and its current regulatory status. The output is not a binder or a report. It is the operational map without which no pipeline can function.
What you will learn3 objectives
By the end of this lesson, you will be able to:
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