Clinical Research Monitor and Auditor

Job Title:

Clinical Research Monitor and Auditor

Requisition Number: RE53822

Working Title:

MCC Auditor & Monitor

Department: 7H025:

CANCER CENTER-CORE SUPPORT

Work Location:

Lexington, KY

Grade Level: 46

Salary Range: $53,/year

Type of Position:
Staff Position

Status:
Full-Time

Schedule:

Monday - Friday, 8:00 am – 5:00 pm (40 hrs/wk). Occasional work outside these hours. Job-related travel.

The Markey Cancer Center (MCC) is recruiting a Clinical Research Auditor/Monitor for Multi-Center Investigator Initiated Trials. The position performs routine audits of MCC trials, study teams, and research programs in accordance with applicable MCC SOPs to assess and assure compliance with protocols, CFR, GCP, sponsor requirements, and MCC SOPs utilizing CTMB guidelines. Duties include data monitoring of MCC IITs, reviewing data accuracy and completeness, performing post audit exit interviews, preparing audit reports with recommendations, following up, evaluating responses, escalating and resolving issues, providing guidance and training, and assisting in the development of training and education initiatives for MCC research staff.

The role utilizes knowledge of FDA Guidance Documents, CFR, GCP, NIH, NCI, ORI, and OMB. It assists in the development and maintenance of master files of audit and monitoring activities, CAPA plans, coordination of audit and monitoring activities, and participation in the MCC QA office and committees.

• Conduct routine audits of MCC trials, study teams, and research programs.
• Assess compliance with protocols, CFR, GCP, sponsor requirements, and MCC SOPs.
• Perform data monitoring of MCC IITs in accordance with CM & DMP.
• Review data accuracy and completeness.
• Conduct post audit exit interviews.
• Prepare audit reports with recommendations and required actions.
• Follow up on audit findings and evaluate responses.
• Escalate and resolve audit issues as needed.
• Provide guidance and training to research staff.
• Assist in developing training and education initiatives.
• Maintain master files of audit and monitoring activities.
• Develop and maintain CAPA plans.
• Coordinate audit and monitoring activities.
• Participate in MCC QA office and report to MCC committees, QA Manager, and ADCT.

• Bachelor’s degree required; preferred advanced degree.
• Minimum 5 years of related experience.
• Certifications:
  
  Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Certified in Healthcare Research Compliance (CHRC), Certified Clinical Research Professional (CCRP), or other nationally recognized certifications.
• Experience with oncology clinical trials and clinical research program audits.
• Knowledge of FDA Guidance Documents, CFR, GCP, NIH, NCI, ORI, and OMB.

• Microsoft Office Proficiency.
• Experience with research databases.
• Knowledge of HIPAA and HSP.
• Strong knowledge of CFR and GCP.
• Knowledge of oncology clinical trials.

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.