Clinical Research Monitor and Auditor

Clinical Research Monitor and Auditor

The Markey Cancer Center (MCC) is recruiting a Clinical Research Auditor/Monitor for Multi-Center Investigator Initiated Trials. This position performs routine audits of MCC trials, study teams, and research programs in accordance with applicable MCC SOPs, to assess and assure compliance with applicable protocols, CFR, GCP, sponsor requirements, and MCC SOPs utilizing CTMB guidelines. Data monitoring of MCC IITS in accordance with CM & DMP.

Review data accuracy and completeness. Perform post audit exit interviews. Prepare audit reports, identifying recommendations and required actions and follow up. Evaluate responses, escalate and resolve. Provide guidance and training. Assist in developing training and education initiatives of MCC research staff. Utilize knowledge of FDA Guidance Documents, CFR, GCP, NIH, NCI, ORI, & OMB. Assist in the development of and maintain master files of audit and monitoring activities.

Assist in the development of CAPA plans. Coordinate audit and monitoring activities. Participate in development of MCC QA office. Participate and report to MCC committees, QA Manager, & ADCT. This position has a hybrid work arrangement and will require travel to other institutions in order to conduct on-site audits. Job related travel is within Kentucky and neighboring states.

Skills / Knowledge / Abilities
- Microsoft Office Pro, research databases, HIPAA, HSP, web, strong knowledge of CFR, GCP; knowledge of oncology clinical trials

Does this position have supervisory responsibilities? - No

Preferred Education/Experience
- Bachelor's degree with more than ten years experience;
Clinical Research Program Audits and Data Monitoring;
Oncology Clinical Research

Final date to receive applications - 08/02/2026

Our University Community
- 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.