UNIV - Quality Assurance Auditor and Education Specialist - Hollings Cancer Center

Medical University of South Carolina; Charleston (SC); On-site; USD 46,000 - 67,000; Full time

Job summary

Ein etablierter Akteur im Gesundheitswesen sucht einen Internal Quality Assurance Auditor und Education Specialist, um die Qualität in der klinischen Forschung zu gewährleisten. In dieser Schlüsselrolle sind Sie verantwortlich für die Durchführung von Audits, Schulungen und die Entwicklung von Bildungsressourcen, um sicherzustellen, dass alle Studienprotokolle eingehalten werden. Sie werden eng mit einem dynamischen Team zusammenarbeiten, um die höchsten Standards in der Forschung zu fördern und die Einhaltung regulatorischer Anforderungen zu gewährleisten. Wenn Sie eine Leidenschaft für Qualitätssicherung und Ausbildung haben, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• Mindestens drei Jahre relevante Erfahrung in klinischer Forschung oder Qualitätsprüfung.
• Tiefes Wissen über FDA, GCP, ICH und andere Vorschriften.

Responsibilities

• Durchführung von Audits für klinische Studien zur Sicherstellung der Protokollkonformität.
• Schulung des Personals zu SOPs, IRB-Richtlinien und GCPs.

Skills

Qualitätsprüfung

Regulatorische Compliance

Schulung und Ausbildung

Datenintegrität

Aufmerksamkeit für Details

Education

Bachelor-Abschluss

Tools

OnCore CTMS

Job description

Job Description Summary

The Internal Quality Assurance Auditor and Education Specialist is an essential member of the Clinical Trials Office (CTO). This position focuses on implementing research quality assurance measures, overseeing education, orientation, and ongoing professional development of research staff involved in human subject oncology clinical research. It also ensures compliance with regulatory standards and promotes excellence in trial execution.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type

Classified

Cost Center

CC001332 HCC CTO Administration

Pay Rate Type

Salary

Pay Grade

University-06

Pay Range

$46,655.00 - $66,488.00 - $86,321.00

Scheduled Weekly Hours

40

Work Shift

Job Description

1. 35% Quality Assurance Internal Auditor
   • Conduct audits of human subject clinical trials within the CTO to ensure protocol compliance, including national cooperative group trials, Phase II, high-risk, and FDA registration trials.
   • Perform new employee enrollment audits focusing on GCP, IRB SOPs, and CTO best practices.
   • Prepare and complete audit reports promptly and accurately, communicate findings to the QAE Program Manager, and document within the clinical trials management system.
   • Qualifications: Deep knowledge of federal, state, institutional, IRB, and CTO regulations; understanding of FDA, GCP, ICH; attention to detail; ability to work independently; effective communication skills.
2. 35% Quality Assurance Education Specialist
   • Collaborate with the QAE Program Manager to onboard and train staff on SOPs, IRB policies, GLPs, GCPs, and ICH Guidelines.
   • Ensure patient eligibility, safety, data integrity, and protocol compliance in oncology research.
   • Conduct training on research documentation, systems, and regulatory compliance.
   • Qualifications: In-depth knowledge of research regulations and ability to train staff on complex topics.
3. 20% Quality Assurance Metrics
   • Track audits and high-risk activities using OnCore CTMS and other tools.
   • Develop educational tools based on performance data, facilitate quality initiatives, and implement CAPAs as needed.
   • Qualifications: Experience in clinical research, quality assurance, or regulatory compliance; ability to develop training materials and manage priorities.
4. 10% Quality Assurance Development
   • Support special projects, process improvement pilots, and committee representations.
   • Contribute to operational efficiency and protocol adherence initiatives.
   • Qualifications: Experience in process improvement projects and strong interpersonal skills for cross-department collaboration.

Additional Job Description

Minimum Requirements: Bachelor's degree and three years of relevant experience.

Physical Requirements: Ability to perform job functions in various physical positions and conditions, including frequent sitting, walking, reaching, and fine motor activities; occasional lifting up to 15 lbs.; good vision and hearing; and ability to work indoors and outdoors.

If you enjoy working with energetic and enthusiastic individuals, you will find a rewarding career with us!

The Medical University of South Carolina is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, age, sex, national origin, gender identity, sexual orientation, disability, veteran status, family or parental status, or any other protected class.

We participate in the federal E-Verify program. For more information, visit http://www.uscis.gov/e-verify/employees.