New River Community College
Quality Assurance Manager
New River Community College, Kansas City, Kansas, United States, 66115
Quality Assurance Manager – Cancer Center
Department:
SOM KC Cancer Center Administration
Job Family Group:
Professional Staff
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. 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 Duties
Perform internal audits of Investigator Initiated Clinical Trials (IITs) conducted at KU Cancer Center to ensure protocol compliance and adherence to SOPs, GCP, and applicable regulatory guidelines.
Work collaboratively with Principal Investigator, CTO Project Directors and other study team members to address concerns following internal and external audits.
Schedule, prepare, and host external audits with pharmaceutical sponsors, CROs, cooperative groups, and academic QA teams, both onsite and remote.
Serve as the primary point of contact for internal audits, external audits, FDA and other regulatory agency inspections before, during and after the audit or inspection.
Prepare for external audits by conducting objective, high‑level reviews of clinical trial information managed by KU Cancer Center, including cooperative groups and pharmaceutical‑sponsored clinical trials.
Collaborate with the PI, clinical study team, regulatory team, correlative laboratory and Investigational Drug Services in preparation for 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 QA resource to KU Cancer Center clients, evaluate problems and provide solutions.
Provide ongoing individual and group training and development of staff, mentoring and coaching, and adherence to organizational policies and procedures as assigned by QA Project Manager.
Participate in Site Initiation Visits (SIVs) and kick‑off meetings to represent QA objectives as assigned by QA Project Manager.
Identify project issues, suggest solutions, and manage problem resolution through expedient and corrective means.
Investigate and respond to CAPA requests by collaborating with study team members, Investigational Drug Services, correlative laboratory and other audit teams.
Provide support to the Data Safety Monitoring Committee Coordinator (DSMC) by generating and reviewing reports, creating meeting agenda, and attending quarterly meetings.
Required Qualifications
Minimum 6 years of relevant work experience (education may substitute on a year‑‑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
Experience with FDA inspections and pharmaceutical sponsor audits.
Skills
Attention to detail, problem solving, time management, multitasking.
Strong interpersonal and communication skills.
Proficient computer skills.
Benefits 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. 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 full details, visit
KUMC Benefits .
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
#J-18808-Ljbffr
SOM KC Cancer Center Administration
Job Family Group:
Professional Staff
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. 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 Duties
Perform internal audits of Investigator Initiated Clinical Trials (IITs) conducted at KU Cancer Center to ensure protocol compliance and adherence to SOPs, GCP, and applicable regulatory guidelines.
Work collaboratively with Principal Investigator, CTO Project Directors and other study team members to address concerns following internal and external audits.
Schedule, prepare, and host external audits with pharmaceutical sponsors, CROs, cooperative groups, and academic QA teams, both onsite and remote.
Serve as the primary point of contact for internal audits, external audits, FDA and other regulatory agency inspections before, during and after the audit or inspection.
Prepare for external audits by conducting objective, high‑level reviews of clinical trial information managed by KU Cancer Center, including cooperative groups and pharmaceutical‑sponsored clinical trials.
Collaborate with the PI, clinical study team, regulatory team, correlative laboratory and Investigational Drug Services in preparation for 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 QA resource to KU Cancer Center clients, evaluate problems and provide solutions.
Provide ongoing individual and group training and development of staff, mentoring and coaching, and adherence to organizational policies and procedures as assigned by QA Project Manager.
Participate in Site Initiation Visits (SIVs) and kick‑off meetings to represent QA objectives as assigned by QA Project Manager.
Identify project issues, suggest solutions, and manage problem resolution through expedient and corrective means.
Investigate and respond to CAPA requests by collaborating with study team members, Investigational Drug Services, correlative laboratory and other audit teams.
Provide support to the Data Safety Monitoring Committee Coordinator (DSMC) by generating and reviewing reports, creating meeting agenda, and attending quarterly meetings.
Required Qualifications
Minimum 6 years of relevant work experience (education may substitute on a year‑‑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
Experience with FDA inspections and pharmaceutical sponsor audits.
Skills
Attention to detail, problem solving, time management, multitasking.
Strong interpersonal and communication skills.
Proficient computer skills.
Benefits 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. 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 full details, visit
KUMC Benefits .
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
#J-18808-Ljbffr