Donna Sellers
Clinical Research Professional
- Role
- Clinical Trial Specialist Ii at UBC
- Location
- Savannah, GA, US
- LinkedIn followers
- 500 followers
Experience
Clinical Trial Specialist Ii
Oct 2022 — Present
Manages all aspects of site operations for clinical trials, including feasibility assessments, training, regulatory compliance, and site management. Executes confidentiality agreement, contract, and budget negotiation with sites. Conducts remote site monitoring visits, ensures patient safety, maintains IRB compliance, and tracks study milestones in CTMS. Prepares, reviews, and approves regulatory documents for site approval and drug release. Develops and maintains Trial Master Files in compliance with FDA, ICH/GCP, and local laws. Supports decentralized trials by developing operational processes, creating educational materials, and authoring project specific procedures for study coordinators and project teams.
Education
Claflin University
Bachelor of Science - BS
2006 — 2010
Claflin University
Master of Science - MS
2010 — 2012
Georgetown American University
Doctor of Medicine - MD
2015 — 2020
Skills
- Websites
- Php
- Mobile Websites
- Internet Marketing
- Ppc
- Server Management
- Html
- Desktop Websites
- Web Development
- SEO
- Mysql
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