Clinical Research Monitor & Auditor

avy objects, repetitive motion, working in confined spaces, exposure to PC screens, sitting for extended periods.

Job Summary

The Markey Cancer Center is recruiting a Clinical Research Auditor/Monitor for Multi-Center Investigator Initiated Trials. Responsibilities include routine audits of trials, study teams, and research programs; assessing compliance with protocols, CFR, GCP, sponsor requirements, and internal SOPs; performing data monitoring; reviewing data accuracy and completeness; conducting post-audit exit interviews; preparing audit reports with recommendations and required actions; evaluating responses, escalating, and resolving issues; providing guidance and training; developing training and education initiatives; maintaining audit and monitoring activity master files; developing CAPA plans; coordinating audit and monitoring activities; participating in QA office development; reporting to MCC committees, QA Manager, and ADCT.

Responsibilities
• Conduct routine audits of MCC trials and study teams according to SOPs.
• Assess and assure compliance with protocols, CFR, GCP, and sponsor requirements.
• Perform data monitoring of MCC IITs in accordance with clinical monitoring plan and data management plan.
• Review data accuracy and completeness.
• Conduct post-audit exit interviews.
• Prepare audit reports with recommendations and required actions.
• Evaluate responses, and coordinate escalation and resolution.
• Provide guidance and training to research staff.
• Assist in developing training and education initiatives.
• Maintain master files of audit and monitoring activities.
• Assist in developing CAPA plans.
• Coordinate audit and monitoring activities.
• Participate in QA office development and committee reporting.

Qualifications
• Bachelor’s degree.
• Minimum five years related experience in clinical research.
• Current certification as a Clinical Research Associate, Clinical Research Coordinator, Certified in Healthcare Research Compliance, Certified Clinical Research Professional, or other nationally recognized certification.
• Knowledge of FDA Guidance Documents, CFR, GCP, NIH, NCI, ORI, and OMB guidelines.
• Strong familiarity with CTMB guidelines for audits and monitoring.

Preferred Experience
• More than ten years experience, including Clinical Research Program Audits and Data Monitoring.
• Experience with oncology clinical research.

Travel and Hybrid Work

Hybrid work arrangement requiring travel within Kentucky and neighboring states to conduct on-site audits.

Skills / Knowledge / Abilities
• Proficiency in Microsoft Office and research databases.
• Knowledge of HIPAA and HSP.
• Strong understanding of CFR and GCP.
• Knowledge of oncology clinical trials.

Equal Employment Opportunity Statement

The University follows both 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.