University of Kansas Medical Center · 1 day ago
Quality Assurance Manager
Kansas City Metro Area
Full-time
Onsite
Mid, Senior Level
$59K/yr - $86K/yr
6+ years expThe University of Kansas Medical 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. The Quality Assurance Manager will ensure that clinical trial processes and procedures are maintained, providing quality control support and direction for clinical trials to achieve quality data and positive outcomes for cancer patients.
EducationHigher EducationUniversities
Responsibilities
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
Qualification
Required
6 years of relevant work experience. Relevant 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
Attention to detail
Problem solving skills
Time Management
Multitasking
Interpersonal skills
Communication
Computer skills
Preferred
Experience with the FDA inspections and pharmaceutical sponsors audits
Benefits
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.
Company
University of Kansas Medical Center
The University of Kansas Medical Center strives to educate exceptional health care professionals.
1001-5000 employees
H1B Sponsorship
University of Kansas Medical Center has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (72)
2024 (71)
2023 (75)
2022 (67)
2021 (67)
2020 (64)
Funding
Current Stage
Late StageTotal Funding
$27MKey Investors
Kauffman FoundationNCATS
2024-11-11Grant
2022-09-21Grant· $27M
Leadership Team
Sean Roberts
Chief Technology Officer
Chris Harper
Chief Information Officer
Recent News
News-Medical.Net
2025-08-26
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