• Home
  • Education
  • New Coordinator Orientation

New Coordinator Orientation

This presentation is part of a workshop sponsored by The NC TraCS Institute, UNC Office of Clinical Trials, and the UNC Network for Research Professionals.

Week 1 Module – Introduction, NRP/ Education, and Office of Clinical Trials
handouts / slides / recording
Week 2 Module – UNC Institutional Review Board Processes, Conflict of Interest
handouts / slides / recording
Week 3 Module – Good Clinical Practice and Study Documentation, Informed Consent Processes, Research Monitor Access
slides / recording
Week 4 Module – Contracts and Clinical Trial Agreements, Billing Coverage Analysis, Budgeting and Accounting of Research Funds, Preparing and Executing NIH Budgets
handouts / slides / recording
Week 5 Module – Study Startup and Roles of Research Personnel, Recruitment Services and CDW, UNC Investigational Drug Services, Investigational Device Management Policy
handouts / slides / recording
Week 6 Module – Investigator-Initiated Study Processes, ClinicalTrials.gov and ICMJE requirements, Investigational Drug and Device studies at UNC
slides / recording

This workshop is strongly recommended for all clinical research coordinators (CRC's) , research assistants, or research administrators who are new to the research role or new to working at UNC. The intent is to introduce new CRC's to the UNC offices involved in clinical trials, the federal and local regulations governing conduct, and provide an overview of best practices utilized in the implementation of clinical research.

Pre-requisites for attending this workshop are completion of the CITI Good Clinical Practice (GCP) and CITI Ethics online courses available at: www.citiprogram.org

The topics covered in this presentation are:

  • Review human subject research protection and the IRB
  • Discuss research compliance and required approvals at UNC
  • Review use of the Clinical Research Management System (CRMS)
  • Review basic elements of contract negotiation and grant management
  • Define appropriate responsibilities for study team members
  • Describe steps for successful implementation of a study
  • Describe appropriate management of study documentation
  • Define Good Clinical Practices (GCP)
  • Review the informed consent process

For questions, please contact Amanda Wood — This email address is being protected from spambots. You need JavaScript enabled to view it. | 919.843.9445.