Clinical Research Monitor and Auditor

University of Kentucky

United States

December 8, 2021

Description

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 $49,504-81,682/year Type of Position Staff Position Time Status Full-Time Required Education

BA

Click here for more information about equivalencies: https:// 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 12/08/2021 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.

Posting Specific Questions

Required fields are indicated with an asterisk ().

  • Describe your previous work experience with monitoring or auditing of clinical trials.
  • (Open Ended Question)

  • Describe your greatest challenge in clinical research or clinical research compliance, and your specific efforts to generate results in regards to this challenge.
  • (Open Ended Question)

  • How many years of paid, full-time employment experience do you have in clinical research monitoring and auditing?
  • None
  • More than 0, up through 1 year
  • More than 1 year, up through 2 years
  • More than 2 years, up through 3 years
  • More than 3 years
  • Please choose the answer that best describes your years of paid, full-time employment experience in oncology clinical research.
  • None
  • More than 0, up through 2 years
  • More than 2 years, up through 5 years
  • More than 5 years
  • Please identify the professional certification(s) that you hold in clinical research, compliance, or project management.
  • SoCRA - CCRP +
  • ACRP - CCRC CCRA
  • HCCA - CHRC
  • SQA - RQAP
  • The College of Medicine recognizes a set of values that guide us in our daily interactions. By applying for a position within our college, you are indicating your commitment and expressing your agreement to our five values. These values are diversity, innovation, respect, compassion, and teamwork. Please choose one of these values and give a specific example when you exhibited this quality in your professional experience.
  • (Open Ended Question)

  • The College of Medicine seeks to attract, develop and retain highly skilled and competent employees, to provide the best experience for every patient, student, and colleague we encounter. If selected for a position, do you agree to abide by the College of Medicine values of diversity, innovation, respect, compassion, and teamwork?
  • Yes
  • No
  • 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. I understand that I will be obligated to comply with the new COVID-19 vaccination requirement prior to starting employment at the University of Kentucky.
  • Yes
  • No
  • Where did you first see this position advertised?
  • UK Jobs Website
  • Employee Referral
  • Print Advertisement
  • Job Fair
  • InsideHigherEd.com
  • HigherEdJobs.com
  • Diverse Issues in Higher Education
  • Oneclick.jobtarget.com
  • Indeed.com
  • Other On-line/Media Advertisement
  • A Colleague, Friend, and/or Family member
  • None of the above
  • Applicant Documents

    Required Documents

  • Resume
  • Cover Letter
  • Specific Request 1
  • Optional Documents