Clinical Team Lead
Clinical Team Lead
In the industry for over 15 years, Andy Shelton has managed clinical teams of various sizes in all phases of clinical research. His therapeutic experience is diverse, including acting as a clinical manager and lead on clinical trials in dermatology, rare disease, general medicine, and respiratory disorders. Most of his experience, however, is in infectious disease, primarily HIV and HCV.
Having served as both Clinical Research Associate and a Clinical Team Lead on over 15 Phase 3 HIV/HCV global clinical trials, Mr. Shelton has been instrumental in managing the clinical operations in all phases of research (in both adult and pediatric populations) during his time in the industry.
Within the infectious disease therapeutic area specifically, he has worked with multiple sponsors and managed multiple vendors, including central labs (e.g. pharmacokinetics, phenotype/genotype, safety). Mr. Shelton has also managed clinical operations on studies enrolling more than 800 subjects at over 200 sites in North America, Europe, Asia, and Australia.
Mr. Shelton has served as the lead facilitator in the identification and selection of investigative sites and led the management of CRAs in both global and regional settings. He has also served as primary lead on multiple global clinical study teams and assisted in the development and authorship of clinical protocols, case report forms, informed consent forms, site and monitor training tools, and clinical monitoring plans.
Additionally, Mr. Shelton has presented at multiple research-related conferences, investigator meetings, and clinical site/sponsor meetings.
Mr. Shelton received his Master’s degree in clinical psychology from Western Carolina University and a BA in psychology from the University of North Carolina at Wilmington.
Why clinical research?
“I developed my passion for research in college and this passion was further refined when I managed a psychology lab in graduate school. Team management was my strength, so a career in clinical research naturally followed. As a CRA on commercial HIV and HCV trials, I quickly learned how to manage clinical sites and comprehend the sometimes immediate impact our work can have on the patients we serve. And as I continue to learn and grow, so does my passion for clinical research.”
This is what drives Andy:
“First and foremost, I strive to make a difference in the lives of the patients that participate in the clinical trials I manage. When my team’s success leads to sponsor success and ultimately changes the lives of the patients that we serve, I am further driven and motivated to work diligently every day. While each day brings its challenges, especially in this industry, I am passionate about thinking critically to manage obstacles and ensure my clinical team operates efficiently and with a focus on quality.”