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

Medical University of South Carolina; Charleston (SC); On-site; USD 46,000 - 87,000; Full time

Job summary

The Internal Quality Assurance Auditor and Education Specialist at a leading university plays a crucial role in ensuring compliance and quality in clinical trials. This position involves conducting audits, training staff, and developing educational materials to enhance research quality. Ideal candidates will have a Bachelor's degree and relevant experience, with strong skills in communication and attention to detail. Join a dynamic team committed to excellence in oncology clinical research.

Qualifications

• Minimum 3 years of relevant experience.
• Deep knowledge of federal, state, and institutional regulations.

Responsibilities

• Conduct audits to ensure protocol compliance.
• Onboard and train staff on SOPs and regulations.
• Track audits and develop training materials.

Skills

Attention to Detail

Communication

Training

Education

Bachelor's degree

Job description

Job Description Summary

The Internal Quality Assurance Auditor and Education Specialist is an integral part of the Clinical Trials Office (CTO). This role focuses on implementing research quality assurance measures and overseeing the education, orientation, and continuous professional development of research staff involved in human subject oncology clinical research. Additionally, this position ensures compliance with regulatory standards and fosters 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 - 86,321.000

Scheduled Weekly Hours

40

Work Shift

Job Description

1. 35% Quality Assurance Internal Auditor
   • Conduct audits within the CTO to ensure protocol compliance, including audits of national cooperative group trials, Phase II trials, high-risk trials, and FDA registration trials.
   • Perform new employee subject enrollment audits focusing on GCP, IRB SOPs, and CTO best practices.
   • Prepare and complete audit reports, communicate findings, and document within the clinical trials management system.
   • Qualifications: Deep knowledge of federal, state, institutional, IRB, and CTO regulations; understanding of FDA, GCP, and ICH regulations; attention to detail; ability to work independently; strong 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.
   • Conduct training on research procedures, documentation, and compliance tools.
   • Qualifications: In-depth knowledge of regulations and policies; ability to train staff effectively.
3. 20% Quality Assurance Metrics
   • Track audits and monitoring activities using OnCore CTMS and other tools.
   • Develop educational materials and training sessions based on data trends.
   • Prepare for sponsor visits and ensure follow-up on audit findings.
   • Qualifications: Experience in clinical research, quality assurance, and training material development.
4. 10% Quality Assurance Development
   • Support initiatives to improve processes and resolve study concerns.
   • Participate in committees and uphold professional standards.
   • Qualifications: Experience in process improvement projects; strong interpersonal skills.

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 standing, sitting, walking, and working outdoors in all weather, with specific physical capabilities outlined.

We encourage energetic and enthusiastic individuals to join our team!

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, or family status. All qualified applicants are encouraged to apply.

Participation in the federal E-Verify program confirms employment eligibility. More information is available at http://www.uscis.gov/e-verify/employees.