Research Quality and Assurance Specialist

About the role

This role requires a highly skilled professional with deep expertise in clinical research regulations and quality systems. You will analyze complex documentation, perform detailed data verification, and manage CAPA follow-up with minimal oversight. The position involves guiding institutional research practices through expert advice, cross-functional collaboration, and developing training materials. Key duties impact regulatory readiness, research integrity, and organizational risk.

Responsibilities

• Analyze complex clinical research documentation
• Perform detailed data verification
• Manage CAPA (Corrective and Preventive Action) follow-up with minimal oversight
• Guide institutional research practices through expert advice and cross-functional collaboration
• Develop and deliver training materials
• Ensure regulatory readiness and research integrity
• Mitigate organizational risk related to clinical research

Requirements

• Thorough knowledge of regulatory requirements, including ICH GCP, FDA CFR, HIPAA, IRB processes, and SOPs
• Familiarity with human anatomy, physiology, and medical terminology
• Experience with clinical research systems such as Complion, Epic, and REDCap
• Minimum of three years of clinical research experience, preferably in Oncology or Hematology
• Bachelor’s degree in science or healthcare; RN degree is a plus

Qualifications

• Certifications such as SOCRA or ACRP are preferred