New River Community College
Quality Assurance Manager - Cancer Center
New River Community College, Kansas City, Kansas, United States, 66115
Quality Assurance Manager – Cancer Center
Department: SOM KC Cancer Center Administration – KMCRI-Administration
Job Summary 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.
Job Description
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.
Work Environment 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 approved by management and must reside in the greater Kansas City metropolitan area. The position may require minimal travel to attend national meetings, etc.
Required Qualifications
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.
Preferred Qualifications
Five years clinical research experience.
Experience with FDA inspections and pharmaceutical sponsor audits.
Skills
Attention to detail.
Problem solving skills.
Time management.
Multitasking.
Interpersonal skills.
Communication.
Computer skills.
Required Documents
Cover letter.
Resume.
Benefits Package Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions. 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. For more information, visit https://www.kumc.edu/human-resources/benefits.html
Employment Type Regular, Full time, Salary.
Compensation Pay range: $58,656.00 – $86,000.00 (minimum, midpoint, maximum).
Application Instructions To learn more and apply online, please visit https://kumc.wd5.myworkdayjobs.com/en-US/kumc-jobs/job/Kansas-City-Metro-Area/Quality-Assurance-Manager_JR009407 or search for position number JR009407 on https://careers.kumc.edu/. Applications must be submitted directly through the KU Medical Center website to be considered for this position. Any applications submitted via email or other website will NOT be reviewed or considered.
Equal Employment Opportunity Statement The University of Kansas Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, ethnicity, ancestry, age, protected veteran or disability status, marital status, parental status, or genetic information. http://policy.ku.edu/IOA/nondiscrimination
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Job Summary 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.
Job Description
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.
Work Environment 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 approved by management and must reside in the greater Kansas City metropolitan area. The position may require minimal travel to attend national meetings, etc.
Required Qualifications
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.
Preferred Qualifications
Five years clinical research experience.
Experience with FDA inspections and pharmaceutical sponsor audits.
Skills
Attention to detail.
Problem solving skills.
Time management.
Multitasking.
Interpersonal skills.
Communication.
Computer skills.
Required Documents
Cover letter.
Resume.
Benefits Package Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions. 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. For more information, visit https://www.kumc.edu/human-resources/benefits.html
Employment Type Regular, Full time, Salary.
Compensation Pay range: $58,656.00 – $86,000.00 (minimum, midpoint, maximum).
Application Instructions To learn more and apply online, please visit https://kumc.wd5.myworkdayjobs.com/en-US/kumc-jobs/job/Kansas-City-Metro-Area/Quality-Assurance-Manager_JR009407 or search for position number JR009407 on https://careers.kumc.edu/. Applications must be submitted directly through the KU Medical Center website to be considered for this position. Any applications submitted via email or other website will NOT be reviewed or considered.
Equal Employment Opportunity Statement The University of Kansas Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, ethnicity, ancestry, age, protected veteran or disability status, marital status, parental status, or genetic information. http://policy.ku.edu/IOA/nondiscrimination
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