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Orientation for New Clinical Research Personnel
April 14 @ 1:30 pm - 4:00 pm
This six-part orientation is strongly recommended for all clinical research personnel who are new to research or new to UNC-Chapel Hill. We will introduce participants to the UNC offices involved in clinical trials, discuss federal and local regulations governing conduct of research, and provide an overview of best practices utilized in the implementation of clinical research. Research personnel are encouraged to attend all modules, but may choose to attend only those of particular interest or relevance.
All sessions are from 1:30 to 4 p.m. — and we are keeping the lines open after the orientation for a discussion and Q/A session!
Mar 17 – Week 1
Introduction, Network for Research Professionals, and Office of Clinical Trials
Mar 24 – Week 2
UNC IRB Processes and Conflict of Interest
Mar 31 – Week 3
GCP, Study Documentation, Informed Consent, Research Monitor Access
Apr 07 – Week 4
Contracts, Clinical Trial Agreements, Planning/Accounting for Funds, and NIH Budgets
Apr 14 – Week 5
Study Startup, Roles of Research Personnel, Recruitment/CDW, UNC IDS, and UNC Device Policy
Apr 21 – Week 6
REDCap, Investigator-Initiated Study Process, ClinicalTrials.gov, Documentation and Assessment of Adverse Events, Investigational Drug/Device Studies at UNC
Handouts and slides for the presentations will be emailed to all registrants. Please contact Marie Rape with any questions.
CEUs: Each session has been pre-approved for 2.5 Contact Hours of Clinical Research Education for re-certification of ACRP’s CCRC®, CCRA®, CPI®. Certificates of attendance will be available at the conclusion of the training.
This workshop series is sponsored by the North Carolina Translational and Clinical Sciences (NC TraCS) Institute, the UNC Office of Clinical Trials, and the UNC Network for Research Professionals (NRP).