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June 1, 2009

Center for Clinical and Translational Science Facilitation Office
By Donna Brassil

Prior to the Clinical and Translational Science Award (CTSA), there was no core of research coordinators to assist investigators. With the CTSA award in 2006, the leadership of the Center for Clinical and Translational Science created the Facilitation Office to provide experienced and certified research coordinators and data entry personnel to researchers. Research coordinators plan, design, and coordinate clinical research studies in collaboration with the investigator and the interdisciplinary team in accord with FDA and GCP (Good Clinical Practice) guidelines. The Research Coordinator can provide services, including:

  • Collaborate with the investigator in developing a protocol, informed consent documents, and other protocol-related documents
  • Submit regulatory documents to the Advisory Committee on Clinical and Translational Science (ACCTS) and the Institutional Review Board (IRB)
  • Create source documents
  • Design Case Report Forms (CRFs)
  • Assist in the conduct of research studies, including obtaining informed consent from participants and conducting participant visits
  • Assist in internal monitoring of studies
  • Prepare documents and materials for auditing visits
  • Maintain regulatory binders

Additionally, the Facilitation Office has developed the Navigation program at Rockefeller University. Under this program, Facilitation Office staff will arrange an interdisciplinary meeting to provide input into the study prior to ACCTS/IRB submission. The goal is to help the investigator by facilitating the investigator’s interaction with staff members with expertise in different aspects of protocol development, implementation, and conduct. The advantages of this process include:
  • Resources for support of protocol development are provided to the investigator
  • Formal feasibility assessments are conducted
  • Anticipated barriers to the conduct of the study are indentified early, including those related to:
    • Screening
    • Inclusion/Exclusion Criteria
    • Enrollment
    • Study completion
    • Study conduct
  • A plan and available tools are put in place so the investigator can start her or his study immediately after approval
If you would like to learn more about the Facilitation Office’s services, need a research coordinator’s assistance, would like to schedule a navigation meeting, need data entry assistance, or have a question about clinical research or Good Clinical Practice (GCP), please contact Donna Brassil, MA, RN, CCRC (dbrassil@rockefeller.edu or ext -7886).