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

MUSC Health; Charleston (SC); On-site; USD 50,000 - 85,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Auditor and Education Specialist to join their Clinical Trials Office. This vital role focuses on ensuring compliance in clinical trials through rigorous auditing and staff training. The successful candidate will collaborate with various teams to enhance educational initiatives and improve operational efficiency. If you are passionate about clinical research and committed to excellence, this opportunity offers a chance to make a significant impact in the field. Join a dynamic environment where your contributions will be valued and your professional growth supported.

Qualifications

• Bachelor’s degree with 3+ years in quality assurance or clinical trials.
• Experience in training staff on SOPs and compliance guidelines.

Responsibilities

• Conduct audits of clinical trials and ensure compliance with regulations.
• Train staff on quality assurance practices and maintain documentation.
• Track and report metrics to improve quality assurance processes.

Skills

Quality Assurance

Clinical Trials

Education and Training

Data Integrity

Regulatory Compliance

Education

Bachelor's Degree

Tools

OnCore CTMS

Job description

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

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Job Description Summary

The Internal Quality Assurance Auditor and Education Specialist is an essential member of the Clinical Trials Office (CTO). This role involves implementing research quality assurance measures and overseeing education, orientation, and ongoing professional development.

Responsibilities

1. 35% Quality Assurance Internal Auditor: Conduct audits of human subject clinical trials within the CTO, including national cooperative group trials, Phase II trials, high-risk trials, and potential FDA registration trials. Prepare for and participate in NCI NCTN audits, MUSC compliance checks, and sponsor quality control visits. Document findings accurately and communicate with the QAE Program Manager.
2. 35% Quality Assurance Education Specialist: Collaborate with the QAE Program Manager to onboard and train staff on SOPs, IRB policies, GCPs, and ICH guidelines. Focus on patient eligibility, safety, data integrity, and protocol compliance. Conduct training sessions and verify source documentation.
3. 20% Quality Assurance Metrics: Track audits and monitoring activities using OnCore CTMS and other tools. Develop educational materials, identify trends, and implement quality improvement initiatives. Prepare reports and collaborate on corrective actions.
4. 10% Quality Assurance Development: Support process improvement projects, represent the CTO on committees, and promote professionalism and teamwork. Assist in pilot initiatives and system assessments to improve compliance and operational efficiency.

Minimum Requirements

A bachelor’s degree and at least three years of relevant program experience are required.

Physical and Other Requirements

Ability to perform job functions in various physical positions, work indoors and outdoors, and meet sensory and mobility requirements as detailed in the original description.

We value energetic, enthusiastic individuals committed to excellence in clinical research.

Equal Opportunity Statement

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. We participate in the E-Verify program to confirm employment eligibility.