Quality Assurance Manager - Cancer Center

Quality Assurance Manager – Cancer Center

Department: SOM KC Cancer Center Administration – KMCRI-Administration

Under the direction of the Quality Assurance Project Manager, the Quality Assurance Manager will work to ensure the Clinical Trial Organization (CTO) established standard processes and procedures are being followed and maintained. Along with the QA team, the QA Manager provides quality control support, assistance and direction for clinical trials supported by KUCC or where KUCC is a participating site. In partnership with the Clinical Trials Office, the QA 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.

• Perform internal audits of 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 applicable Institutional and Regulatory guidelines.
• Work collaboratively with Principal Investigator, CTO Project Directors and other study team members to address concerns following internal and external audits.
• Interact with Pharmaceutical sponsor Quality Assurance auditors, Clinical Research Organization (CRO) auditors, Cooperative group nurse auditors, and other academic institution QA teams in 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.
• Prepare 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.
• Collaborate with Principal Investigator, Clinical study team, Regulatory team, Correlative Laboratory and Investigational Drug Services in preparation of external audits and regulatory inspections.
• Stay current with 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, mentoring, coaching and adherence to organizational policies and procedures as assigned by the Quality Assurance Project Manager.
• Participate in Site Initiation Visits (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.

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…