27 days old

Clinical Research Monitor and Auditor

Lexington, KY 40507
Posting Details

Job Title Clinical Research Monitor and Auditor
Requisition Number RE38245
Working Title MCC Auditor & Monitor
Work Location Lexington, KY
Grade Level 46
Salary Range $50,981-84,115/year
Type of Position Staff
Position Time Status Full-Time
Required Education


Click here for more information about equivalencies: http://www.uky.edu/hr/employment/working-uk/equivalencies
Required Related Experience

5 yrs

Required License/Registration/Certification
CRA, CRC, CHRC, CCRP or other nationally recognized
Physical Requirements
Lifting, pushing, pulling, standing or walking with heavy objects; repetitive motion & working in confined spaces
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:
  1. Resume (required)
  2. Cover Letter (required)
  3. Specific Request 1 (required):
    1. 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 https://www.uky.edu/hr/benefits.

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.
Deadline to Apply 03/23/2023
University Community of Inclusion
The University of Kentucky is committed to a diverse and inclusive workforce by ensuring all our students, faculty, and staff work in an environment of openness and acceptance. We strive to foster a community where people of all backgrounds, identities, and perspectives can feel secure and welcome. We also value the well-being of each of our employees and are dedicated to creating a healthy place 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.

As an Equal Opportunity Employer, we strongly encourage veterans, individuals with disabilities, women, and all minorities to consider our employment opportunities.

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.


Posted: 2023-02-27 Expires: 2023-03-29

Career Employment at UK

UK offers fulfilling careers in diverse fields supporting our teaching, research and health care missions. We also offer a compelling benefits package, including a generous retirement savings match and a supportive work environment distinguished by a respect for the unique work-life needs of every individual. Our culture of learning also provides tremendous support and resources for ongoing education, training and development. 

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Clinical Research Monitor and Auditor

University of Kentucky
Lexington, KY 40507

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