Academic medical centers: navigating institutional bureaucracy, IRB committees, and investigator autonomy
Examines the RC role within academic medical centers, where institutional bureaucracy, investigator autonomy, and multiple IRB structures shape regulatory operations
The AMC paradox
Consider the position of a regulatory coordinator who has just accepted a role at a large academic medical center. The institutional resources are, by any measure, extraordinary. There is a fully staffed institutional review board with a dedicated submissions portal. A research administration office with compliance specialists, contract negotiators, and budget analysts. A department of medicine with its own research committee. A quality assurance office that conducts internal audits. Training infrastructure that includes GCP courses, HIPAA certification, and protocol-specific competency programs. The principal investigator holds an endowed chair and runs more than 20 active studies across multiple clinical departments.