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Quality Assurance and Monitoring Specialist

Posting Details

Position Information

Working Title Quality Assurance and Monitoring Specialist
Classification Title Program Manager
Position Number J0084829
Hours Per Week 40
Department CCC-KU Cancer Ctr-Admin.
Campus Location Kansas City Metro
Student Position No
Position Summary

This position serves as a Quality Assurance Auditor providing quality assurance review, as appropriate, for all phases of clinical and translational research for both internal investigators, the Midwest Cancer Alliance (MCA) and in collaboration with outside clients.

Required Qualifications
  • Bachelor’s degree in life sciences or related field
  • Knowledge of FDA regulations relevant to drugs, devices, biologics
  • Attention to detail with excellent analytical and problem-solving skills
  • Ability to work effectively under periodic stressful conditions
  • Thorough knowledge and understanding of medical, laboratory, and clinical trial concepts and terminology
  • Ability to manage multiple tasks and set priorities and meet deadlines
  • Work within a team approach and be motivated to work consistently in a fast-paced, “customer-focused” environment
  • Excellent organizational and communication skills
  • Computer literate including Microsoft Word, Excel and Access applications
  • Familiarity with clinical management database systems utilizing tables, queries, etc.
  • Minimal travel to attend national meetings, etc.
Preferred Qualifications
  • Previous working knowledge and experience with the FDA and Pharmaceutical sponsors
  • 5 or more years clinical research experience
Environment Office
Physical Requirements Light
Probation Status

Subject to the regulations of the State of Kansas, the Board of Regents and the University of Kansas Medical Center, I understand and agree that I may be subject to a probation period and during the probation period I serve at the pleasure of the Executive Vice Chancellor of KUMC and my employment may be ended at any time during that period.

Hiring Range
EEO Statement

KU Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disability status, or genetic information.

Job Duties

Description of Job Duty

Conduct high level review of all clinical trials managed by the Cancer Center, including cooperative groups, community sites, and industry-sponsored.

Description of Job Duty

Be knowledgeable, stay current, and act accordingly within the framework of regulatory guidelines provided by federal, state, and local regulatory agencies and ethical guidelines pertaining to the clinical research industry.

Description of Job Duty

Act as a Quality Assurance resource to clients of the Cancer Center, evaluate problems and provide solutions.

Description of Job Duty

Responsible for ongoing individual and group training and development of staff, mentoring and coaching, and adherence to organizational policies and procedures as assigned by Director of Quality Assurance.

Description of Job Duty

Promote a positive work environment that is maintained through open and effective communication.

Description of Job Duty

Ensure the effectiveness of the Quality Assurance unit of the KUCC by establishing and fostering strong relationships and efficient interactions with KU Cancer Center investigators, study coordinators, the KUMC community and sponsors.

Description of Job Duty

Ensure quality of deliverables for projects of assigned investigators/clients.

Description of Job Duty

Participate in SIVs and kick-off meetings to represent quality assurance objectives as assigned by the Director of Quality Assurance.

Description of Job Duty

Identify project issues and suggests possible solutions; manage problem resolution through expedient and corrective means.

Description of Job Duty

Other duties as assigned.

Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this posting?
    • KU Medical Center Website
    • KansasWorks
    • Career Builder
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    • Indeed
    • NonProfit Connect
    • Higher Ed Jobs
    • LinkedIn
    • Facebook
    • Twitter
    • University Career Services Page
    • Print or online publication ad
    • Job/field-specific organization website
    • Referred by current/former employee
    • PracticeLink
    • Health eCareers
    • Other - please specify below
  2. * If you selected "other", please specify your referral source.

    (Open Ended Question)

Documents Needed To Apply

Required Documents
  1. Resume
  2. Cover Letter
Optional Documents