UNV - Internal Auditor and Education Specialist - Hollings Cancer Center

Medical University of South Carolina•Charleston, SC

About The Position

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. Reports Directly to the Program Manager of Quality Assurance and Education, (QA&E).

Requirements

In-depth knowledge of federal, state, institutional, IRB, and CTO regulations and policies.
Strong understanding of FDA, GCP, and ICH regulations.
Exceptional attention to detail.
Ability to work independently with minimal supervision, and effective verbal and written communication skills.
In-depth knowledge of federal, state, institutional, IRB, and CTO regulations and policies.
Strong understanding of FDA, GCP, and ICH regulations.
Proven ability to train and educate staff on complex research, regulatory, and procedural topics.
Clinical research, quality assurance, or regulatory compliance in human subject clinical trials.
Knowledge of the clinical research audit processes, sponsor monitoring, and performance reporting in a clinical research setting.
Experience in the development of training materials, SOPs, and quality assurance documentation and ability to work effectively with cross-functional teams and manage multiple priorities.
Experience in leading or supporting process improvement projects or pilots.
Strong interpersonal skills with the ability to collaborate effectively across departments and resolve study-related concerns.
A bachelor's degree and two years of relevant program experience.

Nice To Haves

1-2 years of experience in oncology clinical trial research, with a strong understanding of study protocols, regulatory guidelines, and data management.
A clinical research certification is preferred but not required.

Responsibilities

Quality Assurance Internal Auditor – Responsible for conducting various human subject clinical trial audits within the CTO to ensure protocol compliance. This role includes auditing national cooperative group clinical trials, Phase II trials, high-risk trials, and potential FDA registration trials.
Conduct new employee subject enrollment audits focusing on Good Clinical Practice (GCP), IRB SOPs, and CTO best practices for national studies and other non-monitored trials.
Perform internal reviews in preparation for NCI National Clinical Trials Network (NCTN) audits, MUSC compliance checks, and or sponsor quality control visits for the following content areas, informed consent, eligibility, treatment, adverse events, disease response, and data quality.
Complete audit reports using standard report templates in a timely and accurate manner. Communicates findings to QAE Program Manager and enters findings within the clinical trials management system.
Quality Assurance Education Specialist – Collaborates with the QAE Program Manager to onboard and train CTO staff on Standard Operating Procedures (SOPs), MUSC IRB policies, Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), and ICH Guidelines. This role focuses on patient eligibility and safety, data integrity, and oncology protocol compliance within the Clinical Operations unit.
Ensure patient eligibility and safety, data integrity and oncology protocol compliance.
Demonstrate knowledge of clinical oncology terminology, study coordination, data management roles, HCC internal workflows, and procedures & policies.
Confirm subject eligibility for enrollment and complete source documentation verification for selected case report form fields to ensure data integrity.
Conduct training and education for staff on subject research chart organization, CTSU Open patient registration, Medidata Rave, TRIAD, electronic patient reported outcomes (ePRO), adverse events, response evaluation criteria in solid tumors (RECIST), NCI Specimen tracking systems, research compliance, CTO policies and federal guidelines.
Utilize approved QAE training documents for staff development.
Establish and maintain effective working relationships with HCC and MUSC colleagues.
Proactively plan, prioritize, and manage responsibilities to ensure patient safety, protocol compliance and data integrity.
Quality Assurance Metrics – Responsible for tracking audits and high-risk monitoring activities in the OnCore clinical trial management system (CTMS) and leveraging tools such as the CTO Clinical Data Center, NCI RAVE metrics, performance reports, and subject metrics to develop educational tools and training sessions to address areas of non-compliance and create educational materials and training sessions to address these gaps.
Track sponsor monitor letters, audit reports, and NCI cooperative group performance reports within OnCore CTMS.
Prepare for sponsor visits by collaborating with clinical teams to ensure all necessary activities are completed prior to the visit.
Review follow-ups monitor visit letters and update findings within OnCore QA forms.
Review follow up monitor visit letters and updates findings within OnCore CTMS.
Communicate identified trends and findings with the QAE PM to help develop targeted quality assurance initiatives. This includes process improvements, Standard Operating Procedure (SOP) updates, and the design and implementation of education materials and training sessions.
Collaborate with research teams to update and create training guidance documents.
Develop and implement corrective and preventative action plans (CAPA) as needed to address quality issues and ensure compliance.
Quality Assurance Development - Supports the QAE team leadership in executing special projects and duties to enhance new initiatives or process improvement pilots. This role involves collaborating with ancillary services to resolve study concerns, assessing systems to proactively identify potential protocol compliance issues, and initiating solutions to ensure protocol compliance and staff development.
Contribute to the planning and execution of process improvement pilots aimed at increasing operational efficiency and protocol adherence.
Represent the CTO on MUSC University Committees and/or NCTN (National Cancer Treatment Network) Cooperative Group Committees.
Consistently demonstrate and uphold MUSC’s Standards of Professional Behavior.
Act as a role model for colleagues and staff, promoting professionalism, ethical conduct, and teamwork within the organization.