Specialist - Research Quality and Assurance

About the role

This role requires expertise in clinical research regulations and quality systems. You will analyze detailed documentation, verify data, and manage CAPA follow-up with minimal supervision. The position involves guiding institutional research practices through cross-functional collaboration, developing training materials, and impacting regulatory readiness, research integrity, and organizational risk.

Responsibilities

• Analyze detailed clinical research documentation
• Verify data accuracy and compliance
• Manage CAPA (Corrective and Preventive Actions) follow-up
• Guide institutional research practices through cross-functional collaboration
• Develop training materials for research teams
• Support regulatory readiness and research integrity
• Mitigate organizational risk related to clinical research

Requirements

• Minimum of three years of clinical research experience in monitoring, auditing, or QA/QC
• Bachelor’s degree in science, healthcare, or a related field (RN degree preferred)
• Experience in oncology or hematology research (preferred)

Skills

• Knowledge of regulatory requirements (ICH GCP, FDA CFR, HIPAA, IRB)
• Familiarity with systems such as Complion, Epic, REDCap, and NCI CTSU
• Certifications such as SOCRA or ACRP (preferred)