New Coordinator Orientation

This workshop is recommended for all clinical research coordinators (CRCs), research assistants, or research administrators who are new to the research role or new to working at UNC. The course introduces the UNC offices involved in clinical trials, federal and local regulations governing conduct, and provides an overview of best practices utilized in the implementation of clinical research.

The orientation is divided into 6 weekly modules, held once in the Spring semester and once in the Fall semester, on Wednesday afternoons from 1:30pm to 4:00pm. Research personnel are encouraged to attend all 6 modules, but may choose to attend only those of particular interest or relevance.

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.

Topics covered:

  • 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

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

Questions? Contact Marie Rape | 919.966.6844

Upcoming Sessions

The next series will be held for six Wednesdays in the Fall of 2021. Check back for details.

Recorded sessions are available below.

Orientation recordings and slides

Week 1

Introduction, NRP/ Education, Running a Clinical Trial from CDA to Study Closure, and Office of Clinical Trials

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Topics:

  • Introduction to Orientation Series (Amanda Wood)
  • Network of Research Professionals (NRP) and Educational Programs for Research Personnel (Emily Olsson)
  • Running a Clinical Trial from CDA to Study Closure / OCT Services and Resources (Christine Nelson)

Week 2

UNC Institutional Review Board Processes, Conflict of Interest

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Topics:

  • UNC Institutional Review Board Processes (IRB Analysts / Staff)
  • Conflict of Interest (Joy Bryde)

Week 3

Good Clinical Practice and Study Documentation, Informed Consent Processes, Research Monitor Access

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Topics:

  • Good Clinical Practices and Study Documentation (Juanita Cuffee)
  • Informed Consent Process (Catherine Barnes)
  • Research Monitor Access (Catherine Barnes)

Week 4

Contracts and Clinical Trial Agreements, Billing Coverage Analysis, Budgeting and Accounting of Research Funds, Preparing and Executing NIH Budgets

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Topics:

  • Contracts and Clinical Trial Agreements (Vonzell Jones)
  • Billing Coverage Analysis overview (Andrea Eiring)
  • Budgeting for Clinical Research, Accounting of Funds (Jill Cunnup)
  • Preparing and Executing NIH Grant Budgets (Sandy Barnhart)

Week 5

Study Startup and Roles of Research Personnel, Recruitment Services and CDW, UNC Hospitals Investigational Drug Services, Investigational Device Management Policy

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Topics:

  • Study Start Up and Roles of Research Personnel (Laura Viera)
  • Recruitment Services / Carolina Data Warehouse (Emily Olsson)
  • UNC Hospitals Investigational Drug Services (Andrew Thorne)
  • Hospital Device Management Policy (Amanda Wood)

Week 6

Investigator-Initiated Study Processes, ClinicalTrials.gov and ICMJE requirements, Adverse Event Evaluation and Documentation, and Investigational Drug and Device studies at UNC

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Topics:

  • Investigator-Initiated Study Processes (Valorie Buchholz)
  • ClinicalTrials.gov and ICMJE requirements (Monica Coudurier)
  • Adverse Event Evaluation and Documentation (Marie Rape)
  • IND and IDE Studies at UNC (Amanda Wood)
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