Clinical Research Regulatory & Study Start-Up Coordinator

POSITION SUMMARY Urology Associates, P.C.

is seeking a detail-oriented and regulatory-minded Clinical Research Regulatory & Study Start-Up Coordinator to join our growing Clinical Research Department.

This role serves as the department's primary owner of site regulatory compliance and new study activation, ensuring that every clinical trial is initiated correctly, documented thoroughly, and maintained in a state of continuous inspection-readiness throughout its lifecycle.

This is a fully on-site role; you will be expected to be available Monday thru Friday.

Working in close collaboration with the Clinical Research Department Manager, Principal Investigators (PIs), Clinical Research Coordinators (CRCs), and external sponsors and Contract Research Organizations (CROs), the Regulatory & Study Start-Up Coordinator ensures that all regulatory submissions, essential document collections, IRB communications, and trial master file activities are executed with accuracy and in strict accordance with ICH E6(R2) Good Clinical Practice (GCP) guidelines, applicable FDA regulations (21 CFR Parts 50, 54, 56, and 312/812), and Urology Associates institutional SOPs.

This position plays a critical role in the department's ability to activate studies efficiently and maintain sponsor confidence, audit readiness, and regulatory integrity across a multi-protocol research portfolio.

This role centers on two core functions: Regulatory Compliance - ownership and maintenance of all site-level regulatory documentation, IRB submissions, and TMF/eTMF integrity across active and closing protocols.

Study Start-Up - coordinating the end-to-end site activation process from feasibility through first patient visit, including sponsor document packages, contract and budget support, and site initiation visit (SIV) preparation.