VUMC Vanderbilt Coordinating Center

Overview of Services

The goal of the Vanderbilt Clinical Trials Center is to assist both new and experienced investigators with the review, preparation, and conduct of industry sponsored, investigator initiated clinical research and federally funded clinical research.  Experienced, certified clinical research coordinators are available, both on and off site, to provide complete study coordination on a range of services, such as, study feasibility, logistical considerations , IRB preparation and submission, study start-up, regulatory compliance, participant recruitment, data management, budgetary review and negotiation as well as financial management.  

 

The Vanderbilt Clinical Trials Center is staffed by qualified, experienced, and certified clinical research coordinators who are well versed in the application of Good Clinical Practice (GCP) to their day to day activities.  These multi-disciplinary, registered nurse and non-nurse coordinators, known collectively as the Study Coordinator, provide both on and off-site services to investigators.  Through their unique outreach model, they are able to offer study coordination at multiple sites for multiple investigators simultaneously.

 

While the CTC can provide complete study coordination to an investigator, they can also provide any one of a range of services including, but not limited to:  

  • Site selection and feasibility assessment
  • Budget development and negotiation, facilitate contract negotiations and execution, financial billing compliance approval , financial tracking and management
  • Logistical considerations and planning, study start up and staff training
  • IRB Preparation and submission,  IRB amendments, adverse events, annual reviews
  • Regulatory document compilation and maintenance  (FDA approval of INDs and IDEs, Medicare billing approval)
  • Design of Source documents and Case report forms
  • Patient Recruitment, Screening, Consenting and Follow Up
  • Drug administration, dispensing and accountability
  • Phlebotomy and specimen processing and storage
  • Data management services (data collection, data entry, internal QA/QI audit program)
  • Study close out and archive

Leadership

Bree Burks, Director

Jill Janssen, 

Jessica Collins,

 

For general inquiries, please email vcc@vanderbilt.edu.

Location and hours of operation

Hours Location

7:30 a.m. to 4:30 p.m.        

For Local Clinical Trial Support:

1500 21st Ave. S., Village at Vanderbilt, Suite 3500

 

For Multicenter Clinical Trial Support:

2525 West End, Suite 1440 

Links and Resources

  1. https://medschool.vanderbilt.edu/clinical-trials-center

Services

Name Description