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TRAINING SOLUTIONS

CRA (Clinical Research Associate)
 

The role of a CRA in a clinical trial is very important and there is a wide range of skill sets required spanning knowledge, skills and behaviours. 

  • Introduction to the Clinical Research Industry

  • Understanding Good Clinical Practice (beginner level)

  • The Role of a CRA (short e.g. 2 hours) "Is this a career choice for me?"

  • The Role of a CRA expanded (long e.g. 2-3 days) 

 

Project Management
 

The role of a Project Manager in clinical research is varied, depending on the type of study but all have important themes in common. 

  • Introduction to the basics of Project Management (long e.g. 2 days)

  • Introduction to Line Management skills

Good Clinical Practice & Regulatory

 

ICH-GCP lays down the framework for clinical trials to protect the patients and to produce reliable data. 

  • Understanding Good Clinical Practice (beginner level)

  • Introduction to Clinical Research

  • ICH-GCP (R2) : what has changed?

  • GCP & EU Regulation 

    • The Clinical Trials Regulation EU No. 536/2014​

    • The Clinical Trial Directive 2001/20/EC

    • The GCP Directive 2005/28/EC

...and lots more
 
  • Role of a Lead CRA

  • Clinical Trials Administrator (CTA)

  • Skills training (assertiveness, time management, communication, presenting etc)

  • Train the Trainer

  • GxP Overviews (GMP, GCLP, GDP, GVP)

If there is something that you are interested in and it is not listed here, please email me : fmwallace3@gmail.com

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