Morgan Maziarz

Site Management Associate i @PSI CRO

King of Prussia, PA, US

Served as the primary liaison between site personnel and Clinical Research Associates (CRAs), facilitating query resolution and ensuring timely Electronic Data Capture (EDC) completion- Acted as the main point of contact for investigative sites regarding vendors, study supplies, and access management- Oversaw pre-study testing of site facilities, including scans, MRI/CT qualification questionnaires, test ECGs, and other assessments- Supported Monitors in accurately documenting subject and site event information in the Clinical Trial Management System (CTMS) while tracking the resolution of site issues and action items- Managed the procurement, receipt, inventory, storage, distribution, return, and reconciliation of clinical supplies to ensure compliance with study protocols- Ensured timely submissions and notifications to regulatory and ethics committees by staying up to date on local regulations and guidelines- Coordinated and facilitated site, Trial Master File (TMF), and system audits and inspections, ensuring compliance with study requirements- Maintained and managed the TMF at both site and country levels, regularly filing essential documents and preparing, distributing, and updating Investigator Site Files (ISF) and ISF checklists- Organized and monitored initial and ongoing project training for site teams in all vendor-related systems- Reviewed and managed document translation status to ensure accuracy and compliance with study requirements- Oversaw the proper flow of safety information between investigative sites and study teams to ensure adherence to regulatory and study-specific reporting requirements.

Johns Hopkins Bloomberg School of Public Health

Master's degree

Monmouth University

Bachelor's degree

Spring-Ford Senior High School 9-12 Center

High School Diploma