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Kansas City Metro Area, United States of America
Onsite
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KMCRI-AdministrationJob Duties
Perform internal audits of the Investigator Initiated Clinical Trials (IITs) conducted at The University of Kansas Cancer Center to ensure protocol compliance, and adherence to Clinical Trials Office Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable Institutional and Regulatory guidelines and requirement(s).
Work collaboratively with Principal Investigator, CTO Project Directors and other study team members to address concerns following internal and external audits.
Interact with Pharmaceutical company sponsor Quality Assurance auditors, Clinical Research Organization (CRO) auditors Cooperative group nurse auditors, and other academic institution QA teams in the scheduling, preparation and hosting of external audits both onsite and remote.
Serve as the primary point of contact for internal audits, external audits, FDA and other Regulatory agency Inspections prior to, during and following conclusion of the audit or inspection.
Responsible for the preparation of external audits by conducting objective, high level review of clinical trial information managed by the KU Cancer Center, including Cooperative groups, and Pharmaceutical sponsored clinical trials in preparation for external audits.
Collaborate with Principal Investigator, Clinical study team, Regulatory team, Correlative Laboratory and Investigational Drug Services in preparation of external audits and Regulatory Inspection.
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.
Act as a Quality Assurance resource to clients of The KU Cancer Center, evaluate problems and provide solutions.
Responsible for ongoing individual and group training and development of staff, mentoring and coaching, and adherence to organizational policies and procedures as assigned by Quality Assurance Project Manager.
Participate in SIVs and kick-off meetings to represent quality assurance objectives as assigned by the Quality Assurance Project Manager.
Identify project issues and suggest possible solutions; manage problem resolution through expedient and corrective means.
Investigate and respond to CAPA (Corrective Action and Preventive Action) requests by collaborating with Clinical Trials Office study team members, Investigational Drug Services, Correlative Laboratory and other teams involved with the audit.
Provide support to the Data Safety Monitoring Committee Coordinator (DSMC) by generating and reviewing reports, creating meeting agenda, and attending quarterly meetings.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.
Work Environment:
This position may be eligible for a hybrid work schedule after 6 months. Incumbent will work remotely and on campus based on a set departmental schedule based on management approval and must reside in the greater Kansas City metropolitan area.
This position may require minimal travel to attend national meetings, etc.
Required Qualifications
Work Experience:
6 years of relevant work experience. Education may substitute for experience on a year for year basis.
Experience with FDA regulations relevant to drugs, devices, biologics.
Experience with CAPA (Corrective Action and Preventive Action) plans and responses.
Experience with clinical trial monitoring and/or auditing.
Preferred Qualifications
Work Experience:
Experience with the FDA inspections and pharmaceutical sponsors audits.
Skills
Attention to detail.
Problem solving.
Time Management.
Multitasking.
Interpersonal skills.
Communication.
Computer skills.
Required Documents:
Resume/CV
Cover Letter
Comprehensive Benefits Package:
Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. https://www.kumc.edu/human-resources/benefits.html
Compensation Statement:
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Minimum
$60,800.00Midpoint
$76,000.00Maximum
$91,200.00