Beth Fletcher

I'm a Certified Professional Coder (Apprentice) bringing more than 10 years of analytical experience from pharmaceutical and clinical research environments. I use ICD-10-CM, CPT, HCPCS Level II, AAPC Codify, and Practicode alongside a strong foundation in data quality and regulatory compliance.

At Duke Participant Research Outcomes, I interview, refer, and consent clinical research participants using validated instruments, databases, EHRs, and CRFs including REDCap and Zelta. I support studies across diverse therapeutic areas, communicate with hundreds of participants and candidates, and mentor new interviewers while contributing to training and data-quality initiatives.

Through Fletcher Analytical Services, I led protocol and study-report work supporting OIDP, prepared and reviewed CMC regulatory documents, and built JMP analyses and bespoke datafiles for a major CRO serving more than 100 analysts.

Earlier, at Oriel Therapeutics and PPD Laboratories, I developed analytical programs, product specifications, analytical methods, validation and stability documentation, and scale-up testing technologies. I also managed a five-member team and investigated OOS/OOT results within GMP, GLP, GCP, and HIPAA requirements.