Research Quality and Assurance Specialist

We are seeking a skilled professional to lead clinical research quality and compliance efforts. Responsibilities include: providing expert guidance on regulatory requirements such as ICH GCP, FDA CFR, HIPAA, IRB processes, and SOP adherence; analyzing complex documentation; performing detailed data verification; managing CAPA follow-up; and developing training and educational materials. Qualifications: a minimum of three years of clinical research experience in monitoring, auditing, or QA/QC, with oncology or hematology research experience preferred. A bachelor’s degree in science, healthcare, or related fields is required; RN degree is a plus. Familiarity with systems like Complion, Epic, REDCap, and NCI CTSU is advantageous. Certification such as SOCRA (CCRP) or ACRP is preferred. Skills: strong judgment, decision-making, knowledge of human anatomy, physiology, and medical terminology, and the ability to collaborate across functions to influence research practices. #J-18808-Ljbffr Mental Health Association of Rochester