Coordinate studies per sponsor protocols to ensure subject compliance for the study durationManage medical records requests for review and reconciliationFacilitate the Informed Consent Process per site SOPsCompliance with GCP, CFR, and ICH guidelinesMaintain compliance with SOPs, GCP, CFR, ICH, & HIPPA guidelinesEnsure training compliance with site staff for assigned studiesData into electronic data records and sponsor systemsQuery resolutionManage inventory of supplies and equipment related to the study

Regulatory digitization projectGreet subjects and gather subject information for input subject databasePrepare and ensure relevant patient information available prior to visitsFacilitate and manage medical records requestsManage source reserve with up-to-date copies to support site CRCs

Exemption certificate management in a complex multi-jurisdiction environmentEnsure compliance with federal, state, and local tax jurisdictionsData analysis, cleansing, and reportingProcess Automation

Analyze Employee RecordsQuickly and accurately input record updatesCommunicating with HR Partners and Recruiters to ensure accuracyDaily compiling and reporting of payroll sensitive materialsDesigning and running queries to ensure ongoing profile management