New Coordinator Orientation

This orientation 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 2 modules. Research personnel are encouraged to attend both modules, but may choose to attend only one.

Questions? Contact Catherine Barnes.

Upcoming Sessions

Join the NRP Listserv to be notified of future session dates.

Recorded sessions are available below and on the RCMU website.

Past Orientation Recordings and Slides (Sessions Prior to 2021)

All orientation sessions post-2021 are located on the RCMU website.

Please note: Certificates of attendance are not available for those who watch these recordings outside of the original presentation.

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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