Research Quality and Assurance Specialist

This role requires a highly skilled professional with deep expertise in clinical research regulations and quality systems. Responsibilities include analyzing complex documentation, performing detailed data verification, and managing 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. The candidate must have thorough knowledge of regulatory requirements such as ICH GCP, FDA CFR, HIPAA, IRB processes, and SOPs. Additional skills include familiarity with human anatomy, physiology, medical terminology, and clinical research systems like Complion, Epic, and REDCap. Qualifications include a minimum of three years of clinical research experience, preferably in Oncology or Hematology, with a Bachelor's degree in science or healthcare; RN degree is a plus. Certifications like SOCRA or ACRP are preferred.