Charlotte Jones
Site Management Associate Ii @PSI CRO
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WORK HISTORY
Site Management Associate Ii @PSI CRO
Ensures exchange of information and documentation with sites and vendorsEnsures regulatory and ethics committee submissions and notificationsEnsures proper administration of sites and vendors paymentsCoordinates preparation for and follow-up on site, TMF and systems audits and inspectionsReviews and coordinates site-specific query resolutionReviews and coordinates site-specific EDC completion and provides the site monitor with regular updates on the completion statusSupports the organization of internal team meetings including preparation of agendas and minutesMaintains study-specific and corporate tracking systemsServes as the sites’ primary contact point for vendors, study supplies, and access managementEnsures communication between the sites and off-site facilitiesUnder supervision, ensures on-the-job coaching of Site Management Associates I, Clinical Trial Administrators, and Clinical Operations InternsArranges and tracks initial and on-going project training for site teams in all vendor-related systems Provides training in courier management and study supplies ordering to the site teamChecks the TMF on a site and a country level regularly and files pending documentsPrepares, distributes, and updates Investigator Site Files (ISF) and ISF checklistsProvides Monitors with ISF documents to be filed in the ISF prior to each monitoring visitHolds vendor management calls within the clinical project teamUpdates CTMS with lacking project informationAssists the Monitors in their prompt completion of all subject event and site event information in CTMSAssists the Monitors in their meeting the deadlines for site visits, visit reports and visit letter dates information recording in CTMSTracks the resolution status of site issues and action items in CTMSEnsures proper safety information flow with investigative sites Conducts training of sites coordinators in project-specific safety reporting procedures
EDUCATION
Ardrey Kell High School
High School Diploma
Wake Forest University
Bachelor of Arts (B.A.), English, History
The University of North Carolina at Chapel Hill
Master of Library & Information Science - MLIS, Library Science
SKILLS
ABOUT CHARLOTTE JONES
Site Management Associate II and Acting Project Coordination Associate for clinical trials at PSI CRO with extensive experience in Phase 3 Oncology studies, as well as experience in Phase 3 Complicated UTI studies. Presently serving as sole Project Coordination Associate for North America on large scale Phase 3 Oncology study. Proficient in all phases of the Project Lifecycle (Study Start-Up, Study Maintenance, and Study Close Out). SMA Mentor and former Subject Matter Expert Workshop leader for new clinical operations hires.
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