Katherine Davis

Responsible for ensuring the accuracy, integrity, and compliance of clinical trial data and documentation throughout all stages of research. Supported clinical trial teams by performing quality control checks, maintaining regulatory compliance, and ensuring adherence to Good Clinical Practice (GCP), standard operating procedures (SOPs), and applicable regulations.

Managed clinical trials from initiation to close-out in compliance with regulatory standards (GCP, ICH, FDA, IRB). Skilled in participant recruitment and consent, conducting study visits, and maintaining accurate documentation and databases. Monitored patient safety, handled adverse events, and served as a key liaison with sponsors and regulatory bodies.

Oversaw the strategic, operational, and financial management of the clinical research site. Ensured the successful execution of clinical trials by managing site staff, maintaining regulatory compliance, and fostering strong relationships with sponsors, CROs, and investigators. Focused on high-quality data collection, participant safety, and overall study integrity while driving site performance an

Ensured that all products met established safety, quality, and regulatory standards. This role involved monitoring production processes, conducting inspections, and working closely with production teams to ensure compliance with USDA, FDA, HACCP, and company quality systems. Maintained food safety and product consistency throughout the processing operation.

Completed the CITI Program for GCP in Clinical Trials with Investigational Drugs and Biologics, focusing on regulatory compliance and ethical conduct in clinical research.

Obtained certification in Information Privacy Security through the CITI Program, emphasizing data protection and confidentiality in clinical research settings.

Completed the CITI Program module on Conflicts of Interest, ensuring adherence to ethical guidelines and transparency in research practices.

Received certification in Biomedical Research from the CITI Program, covering foundational principles and best practices in biomedical studies.

Completed training and received certification as a Phlebotomy Technician, gaining expertise in blood collection procedures and patient care.

Graduated with a high school diploma, completing foundational education.