Mitzi Roberson Gregory Kauffman
Site management associate PSI
- Role
- Sma 1 at PSI CRO
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Mitzi Roberson Gregory Kauffman
Over 10 years clinical research experience- Sponsor and CRO experience- ICH, GCP, FDA guidelines (GCP Certificate)- Worked in following areas: Feasibility, Contracts, TMF, Start-up, Finance, Data Mgmt, Maintenance, and Close-out- Budget/Financial/Accruals and Contract negotiations- Regulatory document review- IRB submissions- Global EU submissions/reviews- NDA submission - Remote data entry/IVRS- Site Initiation Visit - co-monitor- INDSRs/SUSAR/SAE/AE review, distribution and tracking- Monitoring visit and letters, tracking and reporting- Investigator Meeting Preparations and Presenting- File QA Auditing for Sponsor and CRO- Data Capture, Viewing and query resolution- Metrics/timelines- ICF ReviewTherapeutic areas:Cardiology CNSGastroenterologyHIV/Infectious DiseaseEndocrinology & Metabolic DiseaseNeurologyOncologyOphthalmologyCardiology
Experience
Sma 1
Oct 2025 — Present
Education
Durham Technical Community College
Associate's degree, Business Administration, Management and Operations
Wake Technical Community College
Certificate in Gerontology, Gerontology
2014
DTCC
Associates, Business/Computer Programming/Operations Mgmt
1998 — 2001
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