Research Quality and Assurance Specialist

About the role

This role requires professional judgment and expertise in clinical research regulations and quality systems. It impacts regulatory readiness, research integrity, and organizational risk.

Responsibilities

• Analyze detailed documentation
• Perform data verification
• Manage CAPA follow-up with minimal oversight
• Guide institutional research practices
• Collaborate across functions
• Develop training and educational materials

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 is a plus)
• Knowledge of regulatory frameworks (ICH GCP, FDA CFR, HIPAA, IRB)
• Familiarity with medical terminology
• Experience with systems like Complion, Epic, REDCap, and NCI CTSU

Qualifications

• Preference for candidates with Oncology/Hematology research experience
• Certifications such as SOCRA or ACRP are advantageous

About us

Join a dedicated healthcare community focused on quality patient-centered care, fostering a supportive team environment and meaningful connections.