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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 of Clinical Research Professionals.

Week 1 Module – Intro, Education, IRB PDF / Recording
Week 2 Module – Study Start Up, Personnel, GCP, Informed Consent PDF / Recording
Week 3 Module – Contracting, CT.gov, BCA, Budgeting, Essential Documents PDF / Recording
Week 4 Module – COI, Grant Budget Development, Investigational Drug and Device Policies, Additional training – HIPAA & Epic PDF / Recording
Week 5 Module – Recruitment, Putting it all together: from CDA to study close out PDF / Recording (audio begins at 7 min mark)

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 Marie Rape — This email address is being protected from spambots. You need JavaScript enabled to view it. | 919.966.6844.

Orientation for New Clinical Research Personnel Series

The next series will be held for five Wednesdays beginning in March 2018 (March 7, 14, 21, 28, and April 4 from 1:30 to 4:00pm) in room 219, Brinkhous-Bullitt Bldg.

This five part orientation is strongly recommended for all clinical research personnel who are new to UNC or new to research. The objectives are to introduce research personnel to the UNC offices involved in clinical trials, discuss the federal and local regulations governing conduct of research, and provide an overview of best practices utilized in the implementation of clinical research.

Register

For questions about this series, please contact Amanda Wood, amanda_wood@med.unc.edu (919.843.9445).