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University of Kentucky is recruiting a Research Regulatory Specialist I to support IRB operations, regulatory documentation, and compliance for clinical trials. The role emphasizes handling IRB processes, HIPAA training, and data organization within a hybrid work setting.
The position requires a BS and at least one year of related experience, with duties including coordination of regulatory activities and support for research teams at the Markey Cancer Center.
The Markey Cancer Center is recruiting a Research Regulatory Specialist I position which is administrative in nature and will assist with the management of Institutional Review Board (IRB) and some financial activities for our clinical trials teams. Duties will include completion of IRB applications with UK and other cancer centers, amendments and renewals, management of all regulatory documentation, responsible conduct of research and human subjects, assure that all center researchers maintain IRB and HIPAA training requirements compose and conduct safety review meetings as needed. Incumbent will also maintain organization database listing for all center projects, including periodic project renewals, and will manage organizational filing of regulatory documents for center research projects. Coordinates and performs a variety of research and administrative activities required in the management of clinical trials research. Duties include coordinating the preparation and submission of reports, documents, and correspondence for regulatory agencies and internal review board; interpreting and applying regulatory and policy requirements to protocols.
This position will have a hybrid work arrangement after the initial training.
Bachelors degree and at least one year of related experience or UK equivalencies.
We value the well-being of each of our employees and are dedicated to creating a healthy place for everyone to work, learn and live. In the interest of maintaining a safe and healthy environment for our students, employees, patients and visitors, the University of Kentucky is a Tobacco & Drug Free campus. The University follows both the federal and state Constitutions as well as all applicable federal and state laws on nondiscrimination. The University provides equal opportunities for qualified persons in all aspects of institutional operations and does not discriminate on the basis of race, color, national origin, ethnic origin, religion, creed, age, physical or mental disability, veteran status, uniformed service, political belief, sex, sexual orientation, gender identity, gender expression, pregnancy, marital status, genetic information or social or economic status. Any candidate offered a position may be required to pass pre-employment screenings as mandated by University of Kentucky Human Resources. These screenings may include a national background check and/or drug screen.