Quality Assurance Manager - Cancer Center
Quality Assurance Manager - Cancer Center
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$ 58656 - 86000
1 Vacancy
Job Description
Department:
SOM KC Cancer Center AdministrationKMCRIAdministrationPosition Title:
Quality Assurance Manager Cancer CenterJob Family Group:
Professional StaffJob Description Summary:
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 only National Cancer Institute designated Comprehensive Cancer Center in the region 1 of only 57 in the nation to receive this distinction. Patients gain access to the most promising therapies cuttingedge clinical trials and world class research.
Job Description:
Job Duties Outlined:
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 andrequirement(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
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 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 Director of Quality Assurance.
Ensure the effectiveness of the KUCC Quality Assurance team by establishing positive and professional relationships with the KU Cancer Center 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.
Participate in SIVs and kickoff meetings to represent quality assurance objectives as assigned by the Director of Quality Assurance.
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.
Required Qualifications:
Education: Associates degree plus two years related work experience OR an equivalent combination of relevant postsecondary education and work experience that equals at least 4 years.
Work Experience:
Two (2) or more years clinical research experience.
Previous experience with 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:
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. Employerpaid life insurance longterm 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. Type: Regular 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. Minimum Midpoint MaximumTime Type:
Full timeRate Type:
SalaryPay Range:
$58656.00 $86000.00
Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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