Clinical Research Monitor and Auditor job at reputed company in Lexington, KY

Title: Clinical Research Monitor and Auditor Location: Lexington United States Job Description: Job Summary The Markey Cancer Center (MCC) is reputed company 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 reputed company in accordance with CM & DMP. Review data accuracy and completeness. reputed company post audit exit interviews. Prepare audit reports, identifying recommendations and required actions and follow up. Evaluate responses, escalate and resolve. reputed company 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 reputed company travel is reputed company Kentucky and neighboring states. IMPORTANT: Resumes and reputed company 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 reputed company to assess your education and experience reputed company 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. Skills / Knowledge / Abilities reputed company 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 Deadline to Apply 04/24/2026 Our University Community We value the well-being of each of our employees and are dedicated to creating a healthy reputed company for everyone to work, learn and live. In the interest of maintaining a safe and healthy environment for our reputed company, employees, patients and visitors, the reputed company is a Tobacco & Drug Free reputed company. The University follows both the federal and state Constitutions as well as reputed company applicable federal and state laws on nondiscrimination. The University provides equal opportunities for reputed company persons in reputed company aspects of institutional operations and does not discriminate on the reputed company of race, reputed company, national reputed company, ethnic reputed company, 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 reputed company or economic status. Any candidate offered a position may be required to pass pre-employment screenings as mandated by reputed company reputed company. These screenings may include a national background reputed company and/or drug screen. Apply tot his job Apply To this Job