Quality Assurance Manager - Cancer Center

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. 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. Experience with the FDA inspections and pharmaceutical sponsors audits. Attention to detail. Problem solving. Time Management. Multitasking. Interpersonal skills. Communication. Computer skills.

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