Regulatory Coordinator
Full course · The Regulatory Coordinator: Role, Scope & Professional Identity
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Addresses the most consequential relationship in the RC's professional life: navigating the line between supporting and assuming the investigator's regulatory responsibilities.
The principal investigator's name appears on the FDA Form 1572. Their medical license underwrites the trial's conduct. Their signature on the protocol agreement constitutes a personal commitment -- to the sponsor, to the IRB, to the regulatory authority -- that this trial will be conducted in compliance with GCP and applicable regulations. When a regulatory authority inspects the site, it is the investigator they hold accountable. Not the coordinator. Not the institution. The investigator.
And yet, at a site running 22 active studies across three therapeutic areas, the investigator cannot personally file every IRB submission, track every training expiration, monitor every continuing review deadline, and chase every safety report follow-up. The volume of operational work exceeds what any single physician can absorb alongside their clinical responsibilities and their nondelegable obligations within those 14 trials. Someone must build and maintain the regulatory infrastructure that makes compliance possible at portfolio scale.
That someone is you.
This creates a professional relationship that has no precise analogy elsewhere in clinical research. You are responsible for ensuring outcomes that depend on someone else's authority. You prepare the materials, but another person must sign them. You track the deadlines, but another person must act on them. You build the systems, but another person retains the ultimate accountability for what those systems produce. Getting this relationship right -- supporting the investigator's regulatory obligations without assuming them -- is, in my experience, the single most consequential skill in the RC's professional repertoire.
What you will learn3 objectives
By the end of this lesson, you will be able to:
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