Research Quality and Assurance Specialist

About the role

The role requires expert judgment in clinical research regulations and quality systems, involving detailed documentation analysis, data verification, and CAPA management with minimal supervision. It influences research practices through guidance, collaboration, and training development, impacting regulatory readiness, research integrity, and organizational risk.

Qualifications

Key qualifications include a minimum of three years of clinical research experience in monitoring, auditing, or QA/QC, with a preference for oncology or hematology expertise. Required education is a bachelor’s degree in science, healthcare, or related fields; RN degree is preferred.

Skills

Knowledge of regulatory standards such as ICH GCP, FDA CFR, HIPAA, IRB processes, and SOPs is essential. Additional skills include familiarity with Complion, Epic, REDCap, NCI CTSU systems, and certifications like SOCRA or ACRP are advantageous.