Regulatory Coordinator
Full course · Regulatory Submissions & Stakeholder Management
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Analyzes deadline conflict types (volume, resource, dependency) and their severity, applies tactical resolution techniques across submission types, and designs automated conflict detection within the regulatory calendar.
The calendar you built in Lesson 1 is now populated. Every deadline, every preparation window, every priority tier is visible across the portfolio. And then you see it -- the two-week period where everything collides.
Two continuing reviews expiring within five days of each other. One initial submission with a sponsor-imposed deadline that cannot slide. A safety amendment the principal investigator has flagged as urgent. A close-out report that the sponsor has been requesting for three weeks. And your most experienced CRC just informed you she will be on medical leave for the entire period.
This is not a hypothetical. Every RC managing more than a dozen studies will encounter this pattern at least once a year -- and many encounter it quarterly. The deadlines converge not because of poor planning but because the external forces driving them -- IRB approval cycles, sponsor program timelines, regulatory authority schedules -- operate independently of each other and independently of the site's capacity.
Course 1 introduced the concept that portfolio management requires resource allocation across competing demands. This lesson makes that concept operational. Here, you will learn to classify the conflicts, assess their severity, and apply specific resolution techniques -- not general principles, but tactical moves that experienced RCs use to navigate periods when the calendar shows more work than the site can absorb.
What you will learn3 objectives
By the end of this lesson, you will be able to:
Progress saves itself — finish reading and this lesson completes
