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

Musckids; Charleston (SC); On-site; USD 46,000 - 67,000; Full time

Job summary

Join a forward-thinking institution as a Quality Assurance Auditor and Education Specialist, where you'll play a vital role in ensuring compliance and excellence in clinical trials. This position involves auditing clinical trials, training research staff, and implementing quality improvement initiatives. If you thrive in a collaborative environment and are passionate about enhancing research quality, this is the perfect opportunity for you. Be part of a dynamic team dedicated to making a difference in oncology research, while enjoying a supportive workplace that values your contributions.

Qualifications

• Minimum Bachelor's degree and 3 years relevant experience required.
• Deep knowledge of research regulations and ability to train staff.

Responsibilities

• Conduct audits of human subject clinical trials for compliance.
• Collaborate to onboard and train staff on SOPs and regulations.
• Track audits and develop educational materials.

Skills

Knowledge of federal, state, and institutional regulations

Understanding of FDA, GCP, and ICH regulations

Effective communication skills

Ability to train staff

Experience in clinical research QA

Detail-oriented

Education

Bachelor's degree

Tools

CTMS

Job description

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

Apply locations Charleston | Time type: Full time | Posted on: Posted 3 Days Ago | Job requisition id: R-0000044440

Job Description Summary

The Internal Quality Assurance Auditor and Education Specialist is a key member of the Clinical Trials Office (CTO). This role involves implementing research quality assurance measures and managing the 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

35% Quality Assurance Internal Auditor - Conduct audits of human subject clinical trials within the CTO to ensure protocol compliance, including audits of national cooperative group trials, Phase II, high-risk, and FDA registration trials. Responsibilities include auditing subject enrollment, preparing audit reports, and communicating findings to the QAE Program Manager.

Qualifications: Deep knowledge of federal, state, institutional, IRB, and CTO regulations; strong understanding of FDA, GCP, and ICH regulations; detail-oriented; able to work independently; effective communication skills.

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. Responsibilities include training staff, verifying source documentation, and ensuring regulatory adherence.

Qualifications: In-depth knowledge of research regulations; ability to train staff on complex topics.

20% Quality Assurance Metrics - Track audits and monitoring activities using CTMS and other tools; develop educational materials; address areas of non-compliance; implement quality improvement initiatives.

Qualifications: Experience in clinical research QA, monitoring, and training material development; ability to manage multiple priorities.

10% Quality Assurance Development - Support process improvement projects, represent the CTO on committees, and promote professionalism and teamwork. Qualifications include experience in process improvement and strong interpersonal skills.

Additional Job Requirements

Minimum: Bachelor's degree and 3 years relevant experience. Physical and sensory requirements include ability to perform job functions in various positions and environments, lifting up to 15 lbs, good vision, hearing, and manual dexterity.

If you enjoy working with energetic, enthusiastic individuals, you'll 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, or other protected categories. All qualified applicants are encouraged to apply.

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