UTMB Clinical and Translational Science Award

项目摘要 自2009年以来，德克萨斯大学加尔维斯顿分校(UTMB)一直是 CTSA财团加速发现更好的健康。我们的中心致力于科学和运营 地方、地区和国家层面的翻译障碍。我们的机构是由一个全系统的 质量方法和我们的CTSA，与严格评估和持续模式一起实施 改进，改变了我们的制度。在开展这些活动时，我们认识到需要更多的 与NCATS进行高效、一致且有影响力的沟通。为了支持这一目标，我们将聘请一名 研究监管专家，具有质量保证/质量控制、人体研究方面的专业知识 法规、项目管理和机构流程。专家将主动精简 流程和改进系统，从而为客户提供更好的服务和更好的翻译结果。 这位新团队成员的角色和职责将与我们CTSA的活动完全结合起来 中心，以促进奖项和相关的人类受试者研究、先导研究、 和学者项目。确保对提交给NCATS和时代的CTSA相关文件进行有效的质量审查 人类主体制度，以及对整个过程的有效管理，将增强我们的能力 推进CTSA财团的使命。

Project Summary Since 2009, the University of Texas Medical Branch at Galveston (UTMB) has worked as a member of the CTSA consortium to accelerate discoveries toward better health. Our Hub addresses scientific and operational barriers to translation at local, regional, and national levels. Our institution is guided by a system-wide approach to quality, and our CTSA, implemented along with a model of rigorous assessment and continuous improvement, has transformed our institution. In conducting these activities, we have identified a need for more efficient, consistent, and impactful communication with NCATS. In support of this objective, we will hire a Research Regulatory Specialist with expertise in quality assurance/quality control, human subjects research regulations, project management, and institutional processes. The Specialist will proactively streamline processes and improve systems, resulting in better service to customers and better translational outcomes. The roles and responsibilities of this new team member will be fully integrated with the activities of our CTSA Hub to facilitate successful administration of the award and associated human subjects research, pilot studies, and scholar projects. Ensuring efficient quality reviews of CTSA-related submissions to NCATS and to the eRA Human Subjects System, as well as effective management of the overall process, will enhance our capacity for advancing the mission of the CTSA consortium.