Specialist - Research Quality and Assurance

Complexity of Work: This role requires professional judgment, decision making, and deep expertise in clinical research regulations and quality systems. Work involves analyzing nuanced documentation, performing detailed data verification, and managing CAPA follow up with minimal oversight. The position influences institutional research practices through expert guidance, cross functional collaboration, and development of training and educational materials. Decisions made in this role directly impact regulatory readiness, research integrity, and organizational risk. Thorough knowledge of regulatory requirements for clinical research, including ICH GCP, FDA CFR, HIPAA, IRB processes, and institutional SOPs. Knowledge of basic human anatomy, physiology, and medical terminology. Required Work Experience: A minimum of three (3) years of clinical research experience with monitoring, auditing, or QA/QC responsibilities required.Oncology and/or Hematology research experience strongly preferred. Other Information: Additional Education Info: Bachelor's degree in science, healthcare, or a related medical field; RN degree preferred.Knowledge of Complion (E-Regulatory system), Epic (EMR) and REDCap Database preferred.Familiarity with NCI CTSU systems, cooperative group research processes, for Clinical Trials in Oncology requirements preferred.SOCRA (CCRP) or (ACRP) certification preferred.

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