Clinical Research Monitor and Auditor
- Location: Lexington, KY
- Posted: Jun 19, 2019
The Clinical Research Monitor & Auditor will perform audits of Markey Cancer Center (MCC) trials, study teams, and research programs in accordance with applicable MCC SOPs, to assess and assure compliance with applicable CFR, GCP, protocols, SOPs, and sponsor requirements utilizing CTMB guidelines. Perform post audit exit interviews. Prepare Audit reports, identifying recommendations and required actions. Evaluate responses, escalate and resolve. Data monitoring of MCC IITs in accordance with CMandDMP. Review data accuracy and completeness. Prepare and provide monitoring reports. 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, and 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, and ADCT.
Microsoft Office Pro, research databases, HIPAA, HSP, web, strong knowledge of CFR, GCP; knowledge of oncology clinical trials.