Melissa Smith
Raleigh
Summary
Proven Clinical Research Associate with a track record of managing 10+ global clinical trials and conducting 50+ site visits annually
Overview
7
7
years of professional experience
Work History
Clinical Research Associate
IQVIA
03.2021 - Current
- Oversaw 5-10 clinical trials simultaneously, ensuring compliance with Good Clinical Practices (GCP) and regulatory requirements.
- Led biweekly cross-functional updates with 7 global teams
- Conducted 50+ site monitoring visits per year, including site initiation, routine monitoring, and close-out visits.
- Successfully recruited 100+ patients for various clinical trials, consistently meeting or exceeding enrollment targets.
- Achieved 99% data accuracy in Case Report Forms (CRFs) through meticulous review and query resolution.
- Maintained audit readiness with zero major findings during sponsor and regulatory audits.
Clinical Trial Assistant
ICON Clinical Research
01.2018 - 03.2022
- Managed and maintained 500+ essential documents for clinical trials, ensuring compliance with regulatory standards.
- Coordinated with 10-15 clinical trial sites, facilitating communication and ensuring timely submission of required documents.
- Entered and verified 1000+ data points in Clinical Trial Management Systems (CTMS) with 99% accuracy.
- Assisted in the preparation and submission of 20+ regulatory documents, achieving a 100% approval rate.
Education
Bachelor of Science -
High Point University
High Point, NCSkills
- Report writing
- Protocols development
- Completing regulatory documents
- Integrated medical reporting
Timeline
Clinical Research Associate
IQVIA
03.2021 - Current
Clinical Trial Assistant
ICON Clinical Research
01.2018 - 03.2022
Bachelor of Science -
High Point University