Shay Smith
New Braunfels,TX
Summary
Dynamic Clinical Trial Coordinator with a proven track record at PPD at Thermo Fisher, excelling in protocol management and regulatory compliance. Demonstrated expertise in data management and a keen eye for detail, ensuring high-quality trial outcomes. Skilled in fostering communication across teams, significantly enhancing project efficiency without compromising accuracy.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Trial Coordinator
PPD at Thermo Fisher
New Braunfels , Texas
11.2023 - Current
- Utilized CTMs and other software tools to efficiently file, manage, and track data records for multiple studies, ensuring accurate documentation and compliance with regulatory standards
- Facilitated communication between sponsors and CROs, sites, and internal departments throughout the course of a trial.
- Responded promptly to queries from regulatory authorities or sponsors regarding protocol amendments.
- Prepared documents for Institutional Review Board submissions.
WOMEN'S SOCCER ASSISTANT
University of Mary Hardin-Baylor
01.2021 - 01.2022
- Company Overview: soccer program
- Soccer program
RESEARCH ASSOCIATE
University of Mary Hardin - Baylor
01.2019 - 01.2021
- Company Overview: Human Performance lab
- Human Performance lab
PACKAGING AND SHIPPING CLERK
Broken Arrow Ranch
01.2021
Education
Bachelor of Science - exercise physiology
Univeristy of Mary Hardin-Baylor
Belton, Texas01.2022
Skills
- Protocol Management
- Detail-oriented
- Regulatory Compliance
- IRB submissions
- Quality Assurance
- Trial Software
- Organization
- Data Management
Certification
ICH - GCP Certified
References
- Dr. Lem Taylor, UMHB Exercise Physiology Director, (254) 780-6210
- Dr. Allen Fields, Executive VP, Clinical & Regulatory Affairs, Head of Research & Development - Avion Pharmaceuticals, (817) 715-7977
Accomplishments
Performance and Body Composition Changes Following an Offseason Training Period in
DIII Collegiate American Football Athletes. International Journal of Exercise Science:
Conference Proceedings. Vol. 2: Iss. 13, Article 70, 2021.
Discovering the Accuracy of Popular Mobile Applications in Predicting Resting Energy
Expenditure in Humans. International Journal of Exercise Science: Conference
Proceedings. Vol. 2: Iss. 13, Article 86, 2021.
Offseason Body Composition Changes Detected by Dual X-Ray Absorptiometry Versus
Multifrequency Bioelectrical Impedance Analysis in Collegiate American Football
Athletes. International Journal of Exercise Science: Conference Proceedings. Vol. 2: Iss.
13, Article 25, 2021.
Comparison of Bioimpedance analysis and Dual Energy X-Ray Absorptiometry in Division
III Football Athletes. International Journal of Exercise Science: Conference Proceedings.
Vol. 2(12); Article 76, 2020.
Lower Limb Muscle Activity and Recruitment Patterns Measured via Electromyography
in Back Squat Variations. International Journal of Exercise Science: Conference
Proceedings. Vol. 2(12); Article 101, 2020.
Timeline
Clinical Trial Coordinator
PPD at Thermo Fisher
11.2023 - Current
WOMEN'S SOCCER ASSISTANT
University of Mary Hardin-Baylor
01.2021 - 01.2022
PACKAGING AND SHIPPING CLERK
Broken Arrow Ranch
01.2021
RESEARCH ASSOCIATE
University of Mary Hardin - Baylor
01.2019 - 01.2021
Bachelor of Science - exercise physiology
Univeristy of Mary Hardin-Baylor
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