Clinical Trial Compliance Administrator

Overview

he position serves as an education and compliance expert regarding federal regulations governing ClinicalTrials.gov. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Clinical research trials must be registered and reported in the publically accessible data base as required by Food and Drug Administration, National Institutes of Health, International Committee of Medical Journal Editors, and the Centers for Medicare and Medicaid Services. This position will administer the University of Kentucky’s ClinicalTrials.gov program, including registration and reporting. The position is responsible for writing, implementing, and maintaining Standard Operating Procedures and University policies, developing training programs for investigators, providing one-on-one assistance for investigator-initiated trials, preparing reports to ensure compliance and to keep institutional leadership updated, and coordinating the program with other compliance offices including Office of Sponsored Projects Administration, Office of Research Integrity, and Office of Corporate Compliance. This position is eligible for remote work.

The University of Kentucky considers the health, safety and well-being of our entire community to be a top priority. In alignment with this priority, all new hires must provide proof of COVID-19 vaccination or obtain an approved medical or religious exemption as a condition of employment. For areas that fall under the federal CMS mandate, start of employment cannot occur until two weeks after receiving the full COVID-19 vaccination series or upon obtaining an approved exemption. Only vaccines approved by the World Health Organization can be accepted.