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Clinical Trials Office

The Clinical Trials Office at Â鶹´«Ã½ supports innovative clinical investigative research at the SLU School of Medicine.

School of Medcine building and fountain
 

Our office provides clinical trial management for industry-sponsored trials, including the oversight of trials and input into their administrative, business, educational, regulatory and operational functions.

The Clinical Trials Office streamlines the processing of research study contracts and budgets with industry partners to facilitate the performance of clinical trials at the Â鶹´«Ã½ School of Medicine.

The office also centralizes important administrative functions and establishes standard policies and procedures for successful management of clinical trials. This ensures the ease of use and proper documentation of all trial procedures.  

A Letter from the Clinical Trials Office

Dear SLU Research Community, 

We are excited to share that our Clinical Trials Office has grown immensely over the past year. With that growth comes new services that the CTO. can offer you and your study teams. We want to introduce to you the three new clinical lead research coordinators that the CTO has hired as a resource to all departments across SLU School of Medicine. Marisol Tahan, Amy Weisguth and Jennifer Lednicky have a wide variety of experience in clinical research and are available to assist in all aspects of the clinical research activities in the SOM.

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

  • Recruitment
  • Enrolling
  • Consenting
  • Scheduling
  • Data collection or processing
  • Regulatory assistance

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 coordinators.

If you are interested in having them help within your research time, please complete the . We would like to introduce you to our new clinical lead research coordinators with some background information about them. 

Marisol Tahan (she/her), (pronounced MEH-ree-soul TAY-han), serves as a clinical lead research coordinator at the Clinical Trials Office, having joined in 2023 to establish a collaborative research services team. With a solid background spanning seven years 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., global clinical operations, and more. Notably, she emphasizes the importance of participant relationships for successful recruitment, retention, and adherence. Marisol is known for her pragmatic approach, leveraging technology to enhance clinical research practices. Her dedication to positive change and compassionate leadership makes her an asset to the research community.

Amy Weisguth is a clinical lead research coordinator in the Clinical Trials Office. She has eight years of experience as a clinical research coordinator with Washington University as well as PPD/Thermo Fisher. She has worked on a variety of clinical trials both federally funded by the NIH and industry-sponsored. Amy has worked in obstetrics and gynecology, gynecologic oncology, general medicine, and vaccine trials. She is well-versed in patient-facing research activities ranging from patient consent and recruitment to specimen collection and processing. Amy prides herself on her ability 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 Clinical Trials Office, Amy will be able to contribute to the needs of various departments with a focus on recruitment planning and execution.

Jennifer Lednicky has joined SLU as a clinical lead research coordinator within the Clinical Trials Office and is very excited to assist in the expansion of research across SLU. Jennifer 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 applied health Behavior Research from Wash U Medical School. In her time at Wash U, Jennifer worked on multiple clinical research studies that looked at brain development and treatments in children/infants to address childhood anxiety and other mental health disorders. Jennifer has experience with all aspects of clinical research from collection of pilot data, applying for funding, getting IRB approval, study start-up all the way to study closeout, dissemination and publication. Within the various studies Jennifer worked on, she established standard SOPs and conducted various procedures including informed consent, Redcap, ct.gov submissions, data collection (including fMRI scans, eye tracking, behavioral assessments, and psychiatric diagnostic interviews). Jennifer is passionate about contributing to projects that will lead to improving healthcare and treatments for the public. She is motivated to learn and assist with any research needs across all departments here at SLU. 

Thank you for your time, and if you are interested in having Marisol, Amy and/or Jennifer help with your research time, please fill out the .  

Best,
Clinical Trials Office

*SLU email needed to access portal.*

Purpose Statement

The primary purpose of the Â鶹´«Ã½ School of Medicine Clinical Trials Office is to improve efficiency and encourage coordination of research efforts among clinical departments.

To achieve this, the office:

  • Facilitates processing of contracts and budgets through standardized policies and procedures.
  • Provides training and education to clinical research personnel.
  • Acts as an informational resource for all research personnel including coordinators, investigators and business managers.
  • Coordinates with SSM Â鶹´«Ã½ Hospital around approval processes, with particular attention to Medicare analysis and other required regulatory activities.

To accomplish its goals, the clinical trials office at SLU, with appropriate departmental input, will:

  • Act as the office of record for all contract documents.
  • Track the projects and contracts.
  • Negotiate the terms of the contract in consultation with departments.
  • Assist with budget preparation and negotiation, if needed, before approval.
  • Assist with compliance regarding research issues.
  • Collect data for internal and external audit purposes.
  • Coordinate amendments and contract terminations.
  • Assist departments in the preparation of paperwork for studies.
  • Maintain an informational website.
  • Train and educate departmental research personnel and principal investigators.
  • Create standard operating procedures for the administration of clinical trials.
  • Provide final signature of agreements and proposals.

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 administrative units.

Regardless of any changes in structure, the office is committed to working closely with University investigators and other research personnel to optimize clinical research operations across the School of Medicine.