Quality Assurance Specialist

Department:
SOM KC Cancer Center Clinical Trials
Clinical ResearchPosition Title:
Quality Assurance SpecialistJob Family Group:
Professional StaffJob Description Summary:
The Quality Assurance Specialist will work to ensure the Clinical Trial Office (CTO) established standard processes and procedures are being followed and maintained. Along with the QA team, the CTO QA Specialist provides quality control support, assistance and direction for clinical trials supported by The University of Kansas Cancer Center (KUCC) or where KUCC is a participating site. In partnership with the QA team, the CTO Quality Team assures clinical trials are being conducted in accordance with Institutional and Regulatory guidelines; therefore, achieving quality and efficacious data and positive clinical outcome with the ultimate goal of innovative, safe, and quality care for cancer patients.
The University of Kansas Cancer Center is the region's only National Cancer Institute designated comprehensive cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.
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 with management approval.Job Description:
Employment conditions

• National travel to attend occasional meetings.

Required Qualifications
Education: Bachelor's degree in a scientific or healthcare related field or an equivalent combination of relevant post-secondary education and work experience equaling four (4) years.
Work Experience:

• Experience using Microsoft Word, Excel and Access.
• 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.
• Experience with medical, laboratory, and clinical trial concepts and terminology.
• Experience using clinical management database systems utilizing tables, queries, etc.

Preferred Qualifications
Education/Certifications: Certified Clinical Research Coordinator (CCRC) or certification eligible, Certified Clinical Research Professional (CCRP) or other research certification.
Work Experience:

• Four (4) or more years clinical research experience.
• Previous working knowledge and experience with the FDA inspections and Pharmaceutical sponsors audits.

Skills:

• Attention to detail.
• Analytical/problem-solving skills.
• Multitasking/Collaboration skills.
• Excellent verbal and written communication skills.

Job Duties Outlined:

• Perform audit resolution after 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 KUCC QA, Principal Investigator, CTO Project Director, and other study team members to address concerns following internal and external audits.
• Develop CAPA follow-up from pharmaceutical company sponsor Quality Assurance audits, Clinical Research Organization (CRO) audits, Cooperative group audits, and other academic institution QA teams.
• Serve as the primary point of contact from the CTO 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 audits by conducting objective, high level review of clinical trial information managed by the KUCC, including Cooperative groups, and Pharmaceutical sponsored clinical trials, and IITs in preparation for audits.
• Collaborate with Principal Investigator, Clinical study team, Regulatory team, Correlative Laboratory and Investigational Drug Services in preparation of external audits and Regulatory Inspection.
• 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.
• Act as a Quality Assurance resource to clients of the KUCC, evaluate problems and provide solutions. Escalate to CTO leadership and the KUCC QA Director, as needed.
• 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 Training and Education.
• Ensure the effectiveness of the CTO Quality Assurance team by establishing positive and professional relationships with the KUCC Principal Investigators, Clinical Trials Office staff including CTO Leadership, Senior Management, Project Management, Clinical Research Coordinators, Clinical Research Data Coordinators, KU Health System staff members and maintain these relationships through constructive and non-punitive communication.
• Represent Quality Assurance objectives as assigned by the Director of Training and Education or CTO Leadership.
• Identify project issues and suggest possible solutions; manage problem resolution through expedient and corrective means.
• Investigate 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.
• Assure completion of CAPA by bridging CTO and KUCC QA, monitoring and tracking trends and reporting these to KUCC leadership.
• Provide support to the Data Safety Monitoring Committee Coordinator (DSMC) by attending quarterly meetings to represent CTO.
• Report quarterly to KUCC leadership on quality metrics determined by CTO and KUCC leadership.
• Create and manage a CTO QC dashboard.
• Develop processes to support CTO execution of KUCC QA Audit findings.
• Quality control checks for new hires following their onboarding and partner with training team to track trends that may need to be revamped or employees that need additional support.
• Analyze deviations and trend analysis reporting to the KUCC/CTO Deviation committee.
• Perform other duties as assigned.

Required Documents:

• Cover letter AND Resume/CV

The University of Kansas Medical Center and The University of Kansas Cancer Center are committed to creating and maintaining a diverse and inclusive learning and working environment, one that nurtures growth and development for all. We encourage individuals with diverse backgrounds to apply!
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 nine 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
Employee Type:
RegularTime Type:
Full timeRate Type:
Salary
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.
Pay Range:
$58,000.00 - $86,000.00
Minimum
$58,000.00
Midpoint
$72,000.00
Maximum
$86,000.00