Training For Clinical Research Coordinators/Site Staff

This is an 8 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 (R2) as well as a comparative view of ICH-GCP E6 (R2) and 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-    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 6-     Investigational Product Training- training covers sources to review IP background as well as IP storage, receipt, dispensation, accountability, and return/destruction

WEEK 7-    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 8-    Reiteration of Lessons Learned- a second look at key aspects of the training received in the previous weeks