Summary
Overview
Work History
Education
Skills
Timeline
Generic

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, NC

Skills

  • 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

Similar Profiles

CREATE PROFILE
Melissa Smith