Lucy Barnett
Birmingham
Summary
Diligent Regulatory Specialist with comprehensive background in coordinating clinical research studies. Successfully managed multiple clinical trials from initiation to closeout, ensuring adherence to regulatory guidelines. Demonstrated ability to effectively communicate with cross-functional teams and maintain meticulous documentation.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Regulatory Specialist
George Washington University Cancer Center
08.2023 - Current
- Assisted in the preparation of regulatory submissions and documentation for review.
- Enhanced regulatory compliance by developing and implementing robust policies and procedures.
- Supported external audits by providing necessary documentation, addressing inquiries, and implementing corrective actions as needed.
- Reviewed and analyzed regulatory documents for accuracy and completeness, identifying potential compliance issues.
Clinical Research Coordinator
George Washington University Cancer Center
06.2022 - 08.2023
- Coordinated clinical trial activities, ensuring compliance with regulatory requirements and protocols.
- Developed and maintained study documentation, ensuring data accuracy and integrity throughout trials.
- Trained and mentored junior staff on clinical trial protocols and best practices.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Research Assistant
Georgetown University
04.2021 - 06.2022
- Assisted nursing staff with medical procedures and patient assessments efficiently.
- Monitored vital signs and reported changes to nursing staff, ensuring timely medical interventions when necessary.
- Performed blood draws, EKGs, and other diagnostic tests accurately and efficiently for prompt analysis by healthcare professionals.
- Processed biological specimens efficiently, ensuring accuracy and adherence to safety protocols.
Education
Master of Science - Nursing
The University of Alabama
Tuscaloosa, AL04-2027
Master of Science - Regulatory Affairs & Clinical Research Leadership
The George Washington University
Washington, DC08-2025
Bachelor of Science - Public Health
University of Alabama
Tuscaloosa, AL12-2020
Skills
- Documentation management
- Specimen handling
- Clinical trial expertise
- Good clinical practices
- Teamwork and collaboration
- Regulatory submissions
Certification
- CITI Good Clinical Practice Training
- CITI Human Subjects Protection Training
- CITI Social & Behavioral Research Training
- CITI Health Information Privacy and Security Training
Timeline
Regulatory Specialist
George Washington University Cancer Center
08.2023 - Current
Clinical Research Coordinator
George Washington University Cancer Center
06.2022 - 08.2023
Research Assistant
Georgetown University
04.2021 - 06.2022
Master of Science - Nursing
The University of Alabama
Master of Science - Regulatory Affairs & Clinical Research Leadership
The George Washington University
Bachelor of Science - Public Health
University of Alabama
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