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临床试验办事处

The 临床试验办事处 at Saint Louis University supports innovative clinical 博彩网址大全医学院的调查研究.

医学院大楼和喷泉
 

Our office provides clinical trial management for industry-sponsored trials, including the oversight of trials and input into their administrative, business, educational, 规管及运作职能.

The 临床试验办事处 streamlines the processing of research study contracts and budgets with industry partners to facilitate the performance of clinical trials 他在博彩网址大全医学院工作.

The office also centralizes important administrative functions and establishes standard 成功管理临床试验的政策和程序. 这样可以确保 所有试验程序的易用性和适当的文件.  

来自临床试验办公室的信

尊敬的博彩网址大全研究界同仁: 

We are excited to share that our 临床试验办事处 has grown immensely over the 过去的一年. 这种增长带来了新的服务,首席技术官. 能提供你和你的吗 研究团队. We want to introduce to you the three new clinical lead research 协调员 that the CTO has hired as a resource to all departments 在博彩网址大全 医学院. Marisol Tahan, Amy Weisguth and 珍妮花 Lednicky have a wide variety of experience in clinical research and are available to assist in all aspects of the clinical research SOM的活动.

The clinical lead research 协调员 within the CTO were hired to serve as floating 协调员 for all CRUs in need of coordinator services; services include:

  • 招聘
  • 招收
  • 自愿的
  • 调度
  • 数据收集或处理
  • 监管援助

Services can be provided on a temporary to long-term basis to fill staffing gaps. These staff members can also serve as a teaching opportunity for new or current research 协调员.

If you are interested in having them help within your research time, please complete the 首席技术官研究服务接收表. We would like to introduce you to our new clinical lead research 协调员 with 一些关于他们的背景信息. 

Marisol Tahan (she/her), (pronounced MEH-ree-soul TAY-han), serves as a clinical lead research coordinator at the 临床试验办事处, having joined in 2023 to establish 合作研究服务团队. 有着七年的扎实背景 in clinical research and a master’s in clinical research management, Marisol has contributed meaningfully to sponsored trials, federally funded research, and various aspects of the field, including Alzheimer's Disease research, clinical software development, Q.A. & Q.C.、全球临床操作等等. 值得注意的是,她强调了这一点的重要性 of participant relationships for successful recruitment, retention, and adherence. Marisol is known for her pragmatic approach, leveraging technology to enhance clinical 研究实践. 她致力于积极的变革和富有同情心的领导 这让她成为了研究界的财富.

Amy Weisguth is a clinical lead research coordinator in the 临床试验办事处. She has eight years of experience as a clinical research coordinator with Washington 以及PPD/赛默飞世尔公司. 她参与过各种临床试验 这两项研究都是由美国国立卫生研究院和工业界资助的. 艾米在产科工作 以及妇科、妇科肿瘤学、普通医学和疫苗试验. She is well-versed in patient-facing research activities ranging from patient consent and 招募标本收集和处理人员. 艾米为自己的能力感到自豪 to develop relationships with her patients and having a positive impact on her projects. She is passionate about helping others and contributing to advances in clinical research. As a part of the 临床试验办事处, Amy will be able to contribute to the needs 负责各部门的招聘计划和执行.

珍妮花 Lednicky has joined 博彩网址大全 as a clinical lead research coordinator within the 临床试验办事处 and is very excited to assist in the expansion of research 在博彩网址大全. 珍妮花 has six plus years of experience as a clinical research coordinator at Washington University’s Department of Child Psychiatry and has her master’s in 华盛顿大学医学院应用健康行为研究. 在华盛顿大学读书期间, 珍妮花 worked on multiple clinical research studies that looked at brain development and treatments in children/infants to address childhood anxiety and other mental health 障碍. 珍妮花 has experience with all aspects of clinical research from collection of pilot data, applying for funding, getting IRB approval, study start-up all the 研究总结、传播和出版的方法. 在各种各样的研究中 worked on, she established standard SOPs and conducted various 程序 including 知情同意,Redcap, ct.提交,数据收集(包括fMRI扫描, 眼动追踪、行为评估和精神诊断访谈). 珍妮花 is passionate about contributing to projects that will lead to improving healthcare 以及对公众的治疗. 她积极主动地学习和协助任何研究 博彩网址大全所有部门的需求. 

Thank you for your time, and if you are interested in having Marisol, Amy and/or 珍妮花 帮助您的研究时间,请填写 首席技术官研究服务接收表.  

Best,
临床试验办公室

临床试验员工门户

*博彩网址大全电子邮件需要访问门户.*

目的宣言

The primary purpose of the Saint Louis University 医学院 Clinical Trials Office is to improve efficiency and encourage coordination of research efforts among 临床部门.

为了实现这一目标,办公室:

  • Facilitates processing of contracts and budgets through standardized policies and 程序.
  • 为临床研究人员提供培训和教育.
  • Acts as an informational resource for all research personnel including 协调员, 调查人员和业务经理.
  • Coordinates with SSM Saint Louis University Hospital around approval processes, with particular attention to Medicare analysis and other required regulatory activities.

To accomplish its goals, the clinical trials office at 博彩网址大全, with appropriate departmental 输入,将:

  • 作为所有合同文件的记录办公室.
  • 跟踪项目和合同.
  • 与各部门协商合同条款.
  • 协助预算准备和谈判,如果需要,在批准之前.
  • 协助遵守有关研究问题.
  • 为内部和外部审计收集数据.
  • 协调合同的修改和终止.
  • 协助各部门准备学习文件.
  • 维护一个信息网站.
  • Train and educate departmental research personnel and principal investigators.
  • Create standard operating 程序 for the administration of clinical trials.
  • 提供协议和提案的最终签名.

As the clinical trials office develops, the range of functions and operations that it can deliver may evolve in conjunction with input from departments, as well as University 行政单位.

Regardless of any changes in structure, the office is committed to working closely with University investigators and other research personnel to optimize clinical research 整个医学院的运作.