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The NextGen Clinical Trial Investigator Training is a virtual five-session educational program designed for faculty who are either involved in clinical trials or who would like to become involved.

The Clinical Research Study Coordinator Bootcamp is a two-day training designed to provide basic knowledge that is beneficial for research coordinators and staff. The program includes lectures, interactive activities, and breakout group exercises.

By the end of this course, learners should be able to:

1. Define the responsibilities of a clinical research coordinator.
2. Understand the principles of good clinical practice.
3. Understand best practices for study start up, conduct and closeout.
4. Understand the resources available to assist with clinical trials at the institutional level.

A Clinical Research Study Coordinator Bootcamp certificate will be provided to those who complete all course modules.

For additional information, please reach out to Veronica Lemme at lemmev@health.missouri.edu.

Details:

• June 6-7, 2024, 8 a.m./8:30 a.m.-4 p.m.
• Lunch provided
• Location: Tom and Linda Atkins Family Seminar Room, Roy Blunt NextGen Precision Health building
• In-person only

 

Agenda

Day One

Session One: June 6 (8-11:30 a.m.)

• Introduction
• Scope and Impact of Clinical Trials at MU
• Good Clinical Practice
• Protocol Breakdown
• Break
• Research Integrity and Compliance (COI)
• IRB
• Recruitment
• Research and the EMR, OnCore, OneDrive and Privacy

Lunch

Session Two: June 6 (12:15-4 p.m.)

• Introduction
• Study Start-up (budgets and contracts)
• Informed Consent 
• Documentation
• Study Conduct and Closeout 
• Break
• Safety and Adverse Event Reporting
• Time Management: A Day in the Life of a Coordinator
• Breakout Sessions (each 30-45 minutes):
  
  • Filling Out the IRB Application
  • Budgeting for Your Trial
  • IITs vs Sponsored Trials

Day Two

Session Three: June 7 (8:30-11:30 a.m.)

• Introduction
• Clinicaltrials.gov (print out of questions for clinicaltrials.gov)
• PI and CRC Responsibilities
• Break
• Working with Study Monitors
• Participant Visit Activity (individual/group activity)
• Consenting and Enrollment Scenarios (group activity)

Lunch

Session Four: June 7 (12:15-4 p.m.)

• Introduction
• Investigational Products: Devices, Drugs and Biologics/IDS Pharmacy
• Lab Management
• Coverage Analysis and Billing
• Break
• Safety and Noncompliance Scenarios (group activity)
• Course Review: Jeopardy (group activity)
• Q&A/Wrap-up