Regulatory Coordinator
Full course · Regulatory Submissions & Stakeholder Management
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Teaches the RC to design, build, and maintain a submission tracking system with fields, statuses, alerts, and maintenance protocols calibrated to portfolio size and IRB complexity.
Every site that grows beyond three or four studies has the same experience. Someone -- usually the most organized coordinator -- creates a spreadsheet to track IRB submissions. It starts simple: study name, IRB, approval expiration date, status. It works beautifully for a few months. Then a new study opens and nobody adds it. A continuing review is submitted but the status is not updated. A column gets accidentally sorted and the dates shift to the wrong rows. The spreadsheet that was once the site's most reliable regulatory tool becomes a source of confusion, and eventually nobody trusts it.
This is not a failure of spreadsheets. It is a failure of system design. The spreadsheet failed because it was built as a document rather than as an operational system -- because nobody defined who updates it, when it gets updated, what each status means, or what happens when the data is wrong. A tracking system is not the tool you use. It is the tool plus the rules that govern its use plus the discipline to maintain it under the sustained pressure of daily operations.
This lesson teaches you to build a tracking system that works at scale -- one that serves as the operational backbone of your submission pipeline and remains reliable even when you are managing 20 concurrent studies through multiple IRBs with a team of coordinators who each have their own way of doing things.
What you will learn3 objectives
By the end of this lesson, you will be able to:
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