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Module 1: Lesson 1
Working with the principal investigator and sub-investigators
Navigate the complex dynamics of supporting investigators who hold ultimate regulatory responsibility while you manage daily operations, including strategies for managing competing demands and communicating concerns.
Fourteen minutes
The principal investigator has 14 minutes between clinic patients. You have three decisions that need investigator input: a participant with a borderline potassium value who is scheduled for dosing tomorrow morning, a sub-investigator who gave you conflicting guidance about a concomitant medication question, and a sponsor call in two hours where the project manager wants the investigator to explain the site's enrollment shortfall.
Fourteen minutes. Three issues. One of them involves participant safety. One involves a disagreement between physicians on your study team. One involves institutional politics and the site's reputation.
If you walk into that 14-minute window and begin with "So, I have a few things to discuss," you will lose the investigator's attention before you finish your first sentence. If you lead with the enrollment call, you have prioritized politics over safety. If you present all three issues with equal urgency, the investigator will address whichever one is easiest and tell you to "send me an email about the rest."
This is the CRC-PI working relationship in its unvarnished reality. Not a partnership of equals reviewing data over coffee--though those moments exist--but a constant negotiation for a scarce resource: the investigator's time, attention, and medical judgment. The coordinators who thrive in this relationship are not the ones who know the most about GCP. They are the ones who have learned to manage upward: to pre-digest information, prioritize ruthlessly, and present decisions in a format that respects the investigator's constraints while protecting what matters most.
This lesson is about developing those skills. Not the regulatory framework of delegation--you covered that in the previous module. This is about the operational craft of working with the person whose name is on the FDA 1572 form, whose medical license is on the line, and whose attention you share with 30 clinic patients, two grant applications, and a department meeting that ran long.
What you will learn
By the end of this lesson, you will be able to: