Training For Clinical Research Coordinators/Site Staff

This is a 12 week course covering all aspects of working as a clinical research coordinator who conducts various roles. 

The training covers: 

WEEK 1-     Introduction to Clinical Research- includes glossary, description of roles,   overview of past research atrocities to explain why regulations are necessary

WEEK 2-     ICH-GCP Overview- training covers ICH-GCP E6 (R3) 

WEEK 3-     Regulatory/Essential Documents Training- training provides details on setting up and managing the Investigator Site File throughout the course of the study

WEEK 4-    Collecting Trial Data and Good Documentation Practices- includes definition of source data and source documents, proper documentation practices, EDC entry and more

WEEK 5 - 9   Clinical Trial Operation- a detailed description of the site staff’s functions, duties and tasks at every aspect of the trial from feasibility to close-out

• Week 5 – Pre-Study/Site Qualification Visits
• Week 6 – Site Initiation Visits
• Week 7 – Interim Monitoring Visits
• Week 8 – IMV EDC & CTMS Exercises
• Week 9 – Close-Out Visit

WEEK 10 -     Investigational Product Training- training covers sources to review IP background as well as IP storage, receipt, dispensation, accountability, and return/destruction

WEEK 11-    Patient Safety- a detailed training covering safety data collection by the site staff as well as assessment of safety issues by the Principal Investigator

WEEK 12-    Reiteration of Lessons Learned- a second look at key aspects of the training received in the previous weeks