Quality Assurance Specialist - Cancer Center

Department:

SOM KC Cancer Center Administration

Clinical Research

Position Title:

Quality Assurance Specialist Cancer Center

Job Family Group:

Professional Staff

Job 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 regions only National Cancer Institute designated comprehensive cancer center where patients gain access to the most promising therapies cuttingedge 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:

Job Duties Outlined:

• Perform audit resolution after internal audits of the Investigator Initiated Clinical Trials (IITs) conducted at the University of Kansas Cancer Center (KUCC) 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.

• Responsible for the preparation ofaudits by conducting objective high level review of clinical trial information managed by the KUCC including Cooperative groups with NCI funding trials 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.

• 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 Senior 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 Senior Director Quality Assurance and/or Executive Director Clinical Operations.

• 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 nonpunitive communication.

• Represent quality assurance objectives as assigned by the Senior Director Quality Assurance and/or Executive Director Clinical Operations.

• 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 in support of trends identified by the Safety Review Committee and support CTO process implementation following review of internal and external 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.

• 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.

Required Qualifications:

Education:

• Bachelors degree in a scientific or healthcare related field oran equivalent combination of relevant postsecondary education and work experience equaling four 4 years.

Work Experience:

• Two 2 or more years clinical research experience.

• Previous working knowledge and experience with the FDA inspections and Pharmaceutical sponsors audits.

• Experience with CAPA (Corrective Action and Preventive Action) plans and responses.

• Experience using clinical management database systems utilizing tables queries etc.

Preferred Qualifications:

Certifications: Certified Clinical Research Coordinator (CCRC) or certification eligible Certified Clinical Research Professional (CCRP) or other research certification.

Skills:

• Computer skills including Microsoft Word Excel and Access.

• Attention to detail.

• Analytical/problemsolving skills.

• Multitasking/Collaboration skills.

• Verbal and written communication skills.

Required Documents:

• Cover Letter

• Resume/CV

Comprehensive Benefits Package: