Job Description

Lifting, pushing, pulling, standing or walking with heavy objects; repetitive motion & working in confined spaces
Shift

Monday - Friday, Day Shift; 8:00 am - 5:00 pm (40 hrs/wk)
Job Summary

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.

When applying, you will need to upload a: * Resume (required)

• Cover Letter (required)
• Specific Request 1 (required):
• a copy of your CCRC, CCRA, CCRP, CHRC, or other nationally recognized research professional certification.

IMPORTANT: Resumes and CVs cannot be substituted for a completed application. Incomplete applications could disqualify you from being considered for this position. If the information on your resume is not entered on the application, this will prevent us from being able to assess your education and experience when trying to determine a salary offer. To be considered 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 and resume. 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 .

This position has been identified as supporting UK HealthCare, which receives funding from the Centers for Medicare and Medicaid Services (CMS). Therefore, all individuals hired into this position must comply with the federal CMS mandate issued in March of 2022. This mandate requires all new hires to provide proof of COVID-19 vaccination or obtain an approved medical or religious exemption as a condition of employment. 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.
Skills / Knowledge / Abilities

Microsoft Office Pro, research databases, HIPAA, HSP, web, strong knowledge of CFR, GCP; knowledge of oncology clinical trials.
Does this position have supervisory responsibilities? No
Preferred Education/Experience

Bachelor\'s degree with more than ten years experience; Clinical Research Program Audits and Data Monitoring; Oncology Clinical Research ; CCRA, CCRC, CHRC, CCRP, RQAP, or other nationally recognized certification in clinical research.

University of Kentucky