Research Quality and Assurance Specialist

Role Overview: This position requires expert judgment and deep knowledge of clinical research regulations and quality systems. The role involves analyzing complex documentation, performing detailed data verification, and managing CAPA follow-up with minimal supervision. Key Responsibilities: Provide guidance to influence research practices, collaborate across teams, and develop training materials. Ensure regulatory compliance, research integrity, and organizational risk mitigation by applying expertise in ICH GCP, FDA CFR, HIPAA, IRB processes, and SOPs. Qualifications & Skills: Minimum of three years in clinical research with monitoring, auditing, or QA/QC. Oncology or Hematology research experience is preferred. Bachelor's degree in science, healthcare, or related field; RN preferred. Familiarity with regulatory systems like Complion, Epic, REDCap, and clinical trial processes is advantageous. Certifications such as SOCRA or ACRP are preferred.