27 days old

Clinical Research Monitor and Auditor

Lexington, KY 40507
Posting Details

Job Title Clinical Research Monitor and Auditor
Requisition Number RE31152
Working Title MCC Auditor & Monitor
Department Name 7H025:CANCER CENTER-CORE SUPPORT
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

BA

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
Shift
Monday-Friday, 8:00am – 5:00pm (40 hrs/wk)
Job Summary
The Markey Cancer Center (MCC) is seeking a Clinical Research Monitor and Auditor to perform audits of MCC trials, study teams, & research programs in accordance with applicable MCC SOPs, to assess & assure compliance with applicable CFR, GCP, protocols, SOPs, & sponsor requirements utilizing CTMB guidelines. Perform post audit exit interviews. Prepare Audit reports, identifying recommendations and required actions. Evaluate responses, escalate and resolve. Data monitoring of MCC IITs in accordance with CM&DMP. Review data accuracy and completeness. Prepare and provide monitoring reports. 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.

The work arrangement for this position is fully onsite.

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 resume, cover letter and Specific Request 1, copy of your currently active CRA, CRC, CHRC, CCRP or other nationally recognized certification.

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

Given the COVID-19 pandemic, and the need to protect our university community including our students, staff, faculty and visitors, the University of Kentucky is requiring COVID-19 vaccination for all new hires prior to starting employment. Therefore, as of October 18, 2021, all new hires prior to their first day of employment must submit appropriate documentation showing, i) completion of the first vaccination against COVID-19, or ii) completion of the full vaccination series against COVID-19, or iii) approved exemption (medical contraindications or a sincerely held religious belief) through the formal exemption process from the COVID-19 vaccination requirement. For those employees who have completed the first vaccination against COVID-19 prior to their first day of employment, the second vaccination (if applicable) must be completed following the vaccination recommended schedule to be considered fully vaccinated.
Skills / Knowledge / Abilities
Microsoft Office Pro, research databases, HIPAA, HSP, EPIC, 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 05/22/2022
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.

Categories

Posted: 2022-04-21 Expires: 2022-05-21

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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