Compliance SpecialistUniversity of Pittsburgh

The University of Pittsburgh, Department of Neurology Stroke Institute, is seeking a qualified Compliance Specialist to support the regulatory and centralizedmonitoring operations of the DUSK clinical trial, serving as part of the Clinical Coordinating Center (CCC).

This individual will work closely with the DUSK Project Manager and the Data Coordinating Center (DCC) to ensure that all participating study sites maintain full compliance with Good Clinical Practice (GCP), IRB requirements, federal regulations, and protocolspecified obligations.

The Compliance Specialist will oversee regulatory documentation workflows, perform remote monitoring activities, support maintenance of the electronic Trial Master File (eTMF), and coordinate riskbased centralized monitoring activities for external sites. They will ensure that all required study documents are current, complete, and properly uploaded, and that site conduct adheres to the approved protocol.

Drives activities and protocols in regard to compliance functions. Assists to mitigate organizational risks, evaluates compliance regulations, and prepares and presents compliance reports to management. Leads compliance and audit training sessions. Ensures adherence to all standards and regulations.

Serves as primary driver of existing controls and protocols designed to manage compliance activities.
• Assists in tracking, analyzing, and mitigating organizational risks and issues related to compliance.
• Evaluates current and new compliance regulations; Ensures adherence to internal standards and compliance with legal regulations.
• Develops, monitors, and presents reports related to compliance management.
• Maintains appropriate documentation of compliance reviews and determinations as required by federal regulations and by university policy.
• Leads training sessions related to compliance and audit.

Must be able to get around a university setting.