Full-Time

Univ – Quality Assurance Auditor and Education Specialist

Updated on 12/12/2024

Medical University of South Carolina

Medical University of South Carolina

Compensation Overview

$46.7k - $86.3kAnnually

Mid

Charlotte, NC, USA

Category
QA & Testing
Manual Testing
Quality Assurance
Required Skills
Google Cloud Platform
Requirements
  • A bachelor's degree and three years of relevant program experience.
  • Knowledge of FDA, GCPs and ICH regulations.
  • Exhibit knowledge of clinical oncology terminology, study coordination and data management roles, HCC internal workflows, procedures and policies.
Responsibilities
  • Responsible for conducting numerous audits within the Clinical Trials office (CTO) to support protocol compliance.
  • Audits may include, but are not limited to national studies, Phase II, high risk, and potential FDA registration trials.
  • Responsible for completing 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.
  • In tandem with the QAE Program Manager participates in onboarding and training CTO staff on Standard Operating Procedures (SOPs), MUSC IRB policies, Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), and ICH Guidelines.
  • May confirm subject eligibility for enrollment and complete source documentation verification (SDV) for selected case report form fields to ensure data integrity.
  • Conducts 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.
  • Within OnCore CTMS is responsible for tracking audits and high-risk monitoring activities.
  • Utilize OnCore, HCC CTO Clinical Data Center, NCI’s RAVE metrics, performance reports, ineligible patient lists, and develops educational tools and training sessions to address areas of non-compliance.
  • Tracks sponsor monitor letters, audit reports and NCI cooperative group performance reports within OnCore CTMS.
  • Reviews upcoming priority sponsor monitor visits and works with clinical teams to ensure activities have been completed prior to the visit.
  • Assists the QAE team leadership with special projects and duties to help carry out new initiatives or process improvement pilots.
Medical University of South Carolina

Medical University of South Carolina

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