Event Details
Event Title Orientation for New Clinical Research Personnel (Sp19)
Location Brinkhous-Bullitt Room
Sponsor NC TraCS (Translational and Clinical Sciences) Institute: NIH CTSA at UNC-CH
Date/Time 03/13/2019 - 04/17/2019
For more information, contact the event administrator: Amanda Wood amanda_wood@med.unc.edu
Sorry, This event has expired
Session Status Session Session Date Start Time End Time Cutoff
Expired Orientation for New Clinical Research Personnel (Week 1) 03/13/2019 1:30 PM 12:00 AM none
Expired Orientation for New Clinical Research Personnel (Week 2) 03/20/2019 1:30 PM 12:00 AM none
Expired Orientation for New Clinical Research Personnel (Week 3) 03/27/2019 1:30 PM 12:00 AM none
Expired Orientation for New Clinical Research Personnel (Week 4) 04/03/2019 1:30 PM 12:00 AM none
Expired Orientation for New Clinical Research Personnel (Week 5) 04/10/2019 1:30 PM 12:00 AM none
Expired Orientation for New Clinical Research Personnel (Week 6) 04/17/2019 1:30 PM 12:00 AM none
 
Orientation for New Clinical Research Personnel - Spring 2019 Series
 
This six 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. Attendees are encouraged to complete both the CITI Good Clinical Practice (GCP) and CITI Human Subjects Protection (IRB/Ethics) modules prior to attending the orientation (available online at: https://www.citiprogram.org/Default.asp)
 
The orientation is divided into 6 weekly modules, held on Wednesdays from 1:30 pm - 4 pm in Room 219 Brinkhous-Bullitt Building (TraCS Institute). Research personnel are encouraged to attend all 6 modules, but may choose to attend only those of particular interest or relevance. The topics to be covered during each module include:
 
March 13, 2019 1:30 PM - 4 PM | Week 1: INTRODUCTION
• Introduction to Orientation Series (Marie Rape) - 1:30 pm - 1:45 pm
• NCRP and Educational Programs for Research Personnel (Terry Hartman) - 1:45 pm - 2:05 pm
• Running a Clinical Trial from CDA to Study Closure / OCT Services and Resources (Christine Nelson / Valorie Buchholz) – 2:05 pm to 4:00pm
________________________________________
 
March 20, 2019 | 1:30 PM- 4 PM | Week 2: IRB
• UNC Institutional Review Board Processes (IRB Analysts / Staff) – 1:30 pm -  3:30pm
• Conflict of Interest (Joy Bryde) - 3:30 pm - 4:00 pm
________________________________________
 
March 27, 2019 | 1:30 PM- 4 PM | Week 3: GCP
• Good Clinical Practices and Study Documentation (Juanita Cuffee) – 1:30pm – 2:45pm
• Informed Consent Process (Marie Rape) – 2:50pm – 3:45pm
• Research Monitor Access (Maria Strubbe) – 3:45pm – 4:00pm
________________________________________
 
April 3, 2019 | 1:30 PM - 4 PM | Week 4: FINANCE
• Contracts and Clinical Trial Agreements (Alison Melvin and Courtney Creekmore) - 1:30 pm - 2:10 pm
• Billing Coverage Analysis overview (Andrea Eiring ) - 2:10 pm - 2:50 pm
• Budgeting for Clinical Research, Accounting of Funds (Jill Cunnup) - 2:55 pm - 3:15 pm
• Preparing and Executing NIH Grant Budgets (Sandy Barnhart) - 3:15 pm - 4:00 pm
________________________________________
 
April 10, 2019 | 1:30 PM - 4 PM | Week 5: POLICY
• Recruitment Services / Carolina Data Warehouse (Emily Olsson) - 1:30 pm - 2:15 pm
• Study Start Up and Roles of Research Personnel (Laura Tuttle) – 2:15pm – 3:10 pm 
• UNC Hospitals Investigational Drug Services (Andrew Thorne) – 3:15 pm – 3:50 pm
• Hospital Device Management Policy (Amanda Wood) - 3:50 pm – 4:00pm
________________________________________
 
April 17, 2019 | 1:30 PM - 4 PM | Week 6: INVESTIGATOR-INITIATED STUDIES
• Investigator-Initiated Study Processes (Chris Nelson / Valorie Buchholz) – 1:30pm- 2:00pm
• ClinicalTrials.gov and ICMJE requirements (Monica Coudurier) – 2:00pm – 2:40pm
• IND and IDE Studies at UNC (Amanda Wood) – 2:45pm – 3:15pm
________________________________________
 
 
Sponsored By NC TraCS (Translational and Clinical Sciences) Institute: NIH CTSA at UNC-CH 
Location: Brinkhous-Bullitt 219
Administrator: amanda_wood@med.unc.edu
Sponsor: NC TraCS (Translational and Clinical Sciences) Institute: NIH CTSA at UNC-CH 
 
For questions, please contact Amanda Wood, amanda_wood@med.unc.edu , 919-843-9445
 
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 NC Translational and Clinical Sciences Institute (NIH CTSA at UNC-CH), UNC Office of Clinical Trials, and the UNC Network of Research Professionals (NRP)
 
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