Research Quality and Assurance Specialist

This role requires expertise in clinical research regulations and quality systems, involving detailed data verification, nuanced documentation analysis, and CAPA follow-up with minimal supervision. It influences research practices through guidance, collaboration, and the development of training materials, directly impacting regulatory readiness, research integrity, and organizational risk. Key responsibilities include ensuring compliance with ICH GCP, FDA CFR, HIPAA, IRB processes, and institutional SOPs. The role demands thorough knowledge of clinical research regulations and basic medical terminology. Qualified candidates will have a minimum of three years of clinical research experience with monitoring, auditing, or QA/QC, with a preference for oncology/hematology background. Required qualifications include a bachelor's degree in science, healthcare, or related fields; RN preferred. Knowledge of systems like Complion, Epic, and REDCap is advantageous, along with familiarity with NCI CTSU, cooperative group research, and certifications like SOCRA or ACRP are preferred. Join a dedicated team committed to delivering quality, patient-centered care, and supporting one another in a collaborative environment.