Clinical Research Monitor and Auditor

Job Title Clinical Research Monitor and Auditor Department 7H025: CANCER CENTER-CORE SUPPORT Location Lexington, KY Job Summary The Markey Cancer Center (MCC) seeks a Clinical Research Auditor/Monitor to perform routine audits of MCC trials, study teams, and research programs in accordance with MCC SOPs. The role assesses compliance with applicable protocols, CFR, GCP, sponsor requirements, and MCC SOPs using CTMB guidelines. Responsibilities include reviewing data accuracy and completeness, conducting post‑audit exit interviews, preparing audit reports with recommendations, escalating and resolving issues, providing guidance and training, and assisting in development of training and education initiatives for MCC research staff. The position supports the development and maintenance of master files of audit and monitoring activities, contributes to CAPA plans, coordinates audits, participates in the development of the MCC QA office, and reports to MCC committees, the QA Manager, and the ADCT. Responsibilities Perform routine audits of MCC trials, study teams, and research programs. Review data accuracy and completeness in accordance with CM & DMP. Conduct post audit exit interviews and prepare audit reports with recommendations. Escalate and resolve audit findings; follow up on required actions. Provide guidance and training to MCC research staff. Assist in developing training and education initiatives. Maintain master files of audit and monitoring activities. Assist in the development of CAPA plans. Coordinate audit and monitoring activities; participate in the development of the MCC QA office. Report to MCC committees, QA Manager, and ADCT. Qualifications Bachelor’s degree with more than ten years of experience. Minimum of 5 years related experience in Clinical Research Program Audits and Data Monitoring for Oncology Clinical Research. Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Certified in Healthcare Research Compliance (CHRC), or Certified Clinical Research Professional (CCRP) certification. Knowledge of FDA Guidance Documents, CFR, GCP, NIH, NCI, ORI, OMB, and oncology clinical trials. Proficiency with Microsoft Office, research databases, HIPAA, HSP, web-based tools. Strong knowledge of CFR, GCP, and oncology clinical trials. Excellent analytical, communication, and training skills. Ability to travel to other institutions in Kentucky and neighboring states. Physical Requirements Job related travel and lifting, pushing, pulling, standing or walking with heavy objects; repetitive motion and working in confined spaces; exposure to PC screens; sitting for long periods of time. Work Schedule Monday‑Friday 8:00 am – 5:00 pm (40 hrs/week). Occasional work outside these hours may be required. Benefits Benefits information is available upon request. Equal Employment Opportunity Statement The University of Kentucky 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. Pre‑Employment Screening Eligible candidates may be required to undergo pre‑employment screening, including a national background check and/or drug screen, as mandated by University of Kentucky Human Resources. #J-18808-Ljbffr