Clinical Research Monitor and Auditor

  • UK HealthCare
  • Lexington, KY, USA
  • Sep 21, 2022
Research

Job Description

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, & research programs in accordance with applicable MCC SOPs, to assess & 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 will have a fully on-site work arrangement and will require travel to other institutions in order to conduct on-site audits. IMPORTANT: To be considered for this position you must fully complete the online application being sure to only put one (1) job title for each entry (multiple job titles for one employer must have separate entries), the # of hours worked per week and your ending salary. You will also be required to upload a cover letter, resume, and as Specific Request 1, a copy of your CCRC, CCRA, CCRP, CHRC, or other nationally recognized research professional certification. To view our exceptional benefits, please visit https://www.uky.edu/hr/benefits. The University of Kentucky considers the health, safety and well-being of our entire community to be a top priority. In alignment with this priority, all new hires must provide proof of COVID-19 vaccination or obtain an approved medical or religious exemption as a condition of employment. For areas that fall under the federal CMS mandate, start of employment cannot occur until two weeks after receiving the full COVID-19 vaccination series or upon obtaining an approved exemption. Only vaccines approved by the World Health Organization can be accepted.

Qualifications

Microsoft Office Pro, research databases, HIPAA, HSP, web, strong knowledge of CFR, GCP; knowledge of oncology clinical trials.

Employment Type

Full-Time