Clinical Research Monitor and Auditor at University of Kentucky – Lexington, Kentucky

BA

5 yrs

Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Certified in Healthcare Research Compliance (CHRC), Certified Clinical Research Professional (CCRP) or other nationally recognized

Job related travel, lifting, pushing, pulling, standing or walking with heavy objects; repetitive motion & working in confined spaces; exposure to PC screens; sitting for long periods of time.

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

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 has a hybrid work arrangement and will require travel to other institutions in order to conduct on-site audits. Job related travel is within Kentucky and neighboring states.
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, resume, and as Specific Request 1, a copy of your CCRA, CCRC, CHRC, CCRP, or other nationally recognized research professional certification.

To view our exceptional benefits, please visit https://www.uky.edu/hr/benefits.

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

Bachelor’s degree with more than ten years experience; Clinical Research Program Audits and Data Monitoring; Oncology Clinical Research

We value the well-being of each of our employees and are dedicated to creating a healthy place for everyone to work, learn and live. In the interest of maintaining a safe and healthy environment for our students, employees, patients and visitors, the University of Kentucky is a Tobacco & Drug Free campus.

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.

Any candidate offered a position may be required to pass pre-employment screenings as mandated by University of Kentucky Human Resources. These screenings may include a national background check and/or drug screen.