VIRGINIA COMMONWEALTH UNIVERSITY

Center for Rehabilitation Science and Engineering

Research Coordination

The VCU-CERSE Research Study Coordination Unit is made up of dedicated research staff with expertise in protocol management, study implementation, and study coordination. The unit consists of research coordinators and clinical research assistants. We have experience developing and conducting research trials in both biomedical and behavioral disciplines.

Our Research Study Coordination Team offers the following services:

Study Start-up

  • Preparing and submitting:
    • Institutional Review Board (IRB) application
    • Scientific Review Committee (SRC) application
    • Protocols
    • Consent forms
    • Approach letters/recruitment materials
  • Completing regulatory forms and gathering regulatory documents
  • Coordinating and facilitating site-initiation visits
  • Coordinating hospital service setup
  • Designing databases

Study Coordination

  • Recruiting and screening patients
  • Assisting with determining eligibility
  • Obtaining consent for minimal-risk studies
  • Scheduling research procedures
  • Facilitating research visits
  • Coordinating shipment of research specimens
  • Coordinating clinical exams (x-rays, MRIs, etc.)
  • Managing data collection
  • Preparing and submitting IRB and SRC amendments and renewals
  • Explaining study basics to patients and families
  • Facilitating study monitor visits
  • Coordinating Data and Safety Monitoring Board (DSMB) meetings
  • Assisting Principal Investigator in monitoring and reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)

Study Closeout

  • Coordinating and monitoring study closeout visits
  • Verifying that studies meet IRB standards for study closure
  • Preparing and submitting IRB and SRC closure notification
  • Performing data resolution
  • Facilitating research file and data storage

Research coordinator services may be available to affiliate faculty on a fee for service basis. For more information on how to access these services contact:

Justin O. Alicea
Research Coordinator
joalicea@vcu.edu
804-628-1355