Clinical Research Training for Junior CRAs

This two-day course will train you in the basic yet crucial areas of clinical monitoring.

Duration
2 days
Profession
Junior Clinical Research Associates, Clinical Trial Assistants, Clinical Trial Coordinators
Course fee
€ 1.000 (excl. VAT)

Short description

By focusing on the different phases of the life cycle of a clinical trial, all typical tasks of a Clinical Research Associate (CRA) will become clear to you; from selecting the investigators to study site close-out, with a strong focus on the “monitoring practice”.
This course is specifically designed for people who have between zero to twelve months experience.

The purpose of the course is to enable you as a CRA to implement the GCP requirements into your daily monitoring tasks. Please note that, in order to ensure a good course result, it is an admission requirement that you have previously followed a course on "Good Clinical Practice (GCP)".

In case you are not yet GCP trained, you may take the ICH-Good Clinical Practice training by ECCRT or any other accredited GCP course before attending this course.

Objectives

  • To understand the basics and phases of clinical research
  • To grasp overall legislative requirements
  • To be familiar with expected job tasks of a CRA from the start to the end of a clinical trial
  • To comprehend trial documentation

Target group

No prior knowledge of clinical research is required. This training is a must for all junior CRAs, experienced Clinical Trial Assistants and Clinical Trial Coordinators. It is also beneficial to people working in related areas such as clinical data processing, (bio-) statistics, regulatory affairs, etc.

Program

Day 1 and 2

 

• Introduction to clinical research
• Overview of the applicable legislation
• The life cycle of a clinical trial
• Monitoring activities at different stages
• Trial documents and trial management in practice: study subject recruitment & management, source data verification, investigational product management, safety reporting, clinical data monitoring and quality assurance

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100

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Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.

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