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MUSC Health · 5 months ago

UNV - Internal Auditor and Education Specialist - Hollings Cancer Center

Charleston

Full-time

Onsite

Entry, Mid Level

$48K/yr - $88K/yr

2+ years exp

The Medical University of South Carolina is seeking an Internal Quality Assurance Auditor and Education Specialist for their Clinical Trials Office. This role focuses on implementing quality assurance measures for oncology clinical research and overseeing the education and development of research staff to ensure compliance with regulatory standards.

Health CareHospitalMedical

Responsibilities

Responsible for conducting various human subject clinical trial audits within the CTO to ensure protocol compliance

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

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

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

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

Communicate identified trends and findings with the QAE PM to help develop targeted quality assurance initiatives

Support the QAE team leadership in executing special projects and duties to enhance new initiatives or process improvement pilots

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

Qualification

Oncology clinical trial researchQuality assurance auditingRegulatory complianceClinical research certificationTrainingEducationData managementAttention to detailEffective communicationInterpersonal skills

Required

A bachelor's degree and two years of relevant program experience

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

Effective verbal and written communication skills

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

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

Preferred

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

Company

MUSC Health

MUSC Health provides health-care services through its patient- and family-centered care, education, research, and various partnerships. It is a sub-organization of Medical University of South Carolina.

Founded in 1824

Charleston, South Carolina, USA

10001+ employees