UT Southwestern Medical Center - Dallas, TX
posted 3 months ago
UT Southwestern Medical Center is seeking a Senior Regulatory Analyst for the Human Research Protection program. This role requires an expert-level understanding of federal regulations and institutional policies related to human and animal research protections. The Senior Regulatory Analyst will be responsible for reviewing complex scientific research documents, identifying ethical and regulatory issues, and may approve protocol submissions. The position involves documenting the decision-making process in accordance with federal regulations, providing guidance to research committee staff and researchers, and resolving complex issues that arise during the regulatory review process. In addition to reviewing submissions, the Senior Regulatory Analyst will direct, analyze, coordinate, and evaluate research committee operations and procedures. This includes summarizing judgments and resolutions of issues for each item under review, reading relevant literature, and attending training sessions to stay current on regulatory changes. The role also involves providing education and training to faculty and study staff, preparing and tracking incident notifications, and responding to inquiries from federal agencies and institutional leadership. The Senior Regulatory Analyst will establish goals and objectives for the research committee, oversee quality control activities, and ensure the effectiveness of internal controls. This position is critical in maintaining compliance with federal regulations and institutional policies, thereby ensuring the protection of research subjects and the integrity of the research process.