Clinical Research Associate Training CRA

products-servicesCROPHA s.p.r.l
May 30th 2012

Crophas’ Clinical Research Associate (CRA) training will enable you to assist with clinical trials of new pharmaceuticals, medical devices or treatment methodologies.

A Clinical Research Associate assists in the design, preparation, planning, implementation and review of a clinical trial to ensure it adheres to regulatory and ethical standards and will communicate these findings to the research team.

On completion of this course you will be equipped with the knowledge and skills required to start work as a fully qualified CRA. The course focuses on both the theoretical and practical issues of monitoring clinical trials. A CRA is responsible for ensuring that any clinical study is conducted in accordance with protocol and Good Clinical Practice (GCP) and complies with legislation. The course covers core GCP and all regulations with regards to human experimentation.

Who is the course suited for:
• Nurses
• Graduates in life sciences (biology, chemistry, pharmacy etc.)
• Doctors
• Physiotherapists

Day 1 – Introduction to Clinical Research, Regulation, Informed Consent
Module course content:

• A full description of the role of a CRA and the qualities needed to perform in this role will be explained along with a full introduction to the clinical research field in the pharmaceutical sector.
• The regulations concerning human experimentation in accordance with the European Directive on Human Experimentation which was implemented in Belgium in 2004.
• Ethics Committees and Competent Authority rules and requirements are covered.
• Rules associated with the commencement, changes, reporting of a SUSAR (Suspected Unexpected Serious Adverse Reaction) and closure of a clinical study.
• How to verify the content of an informed consent.
• Approved procedures for obtaining a written consent from any subject taking part in a clinical trial.
• Requirements to be followed for under age and of age subjects.

Days 2- 6 Site Identification (1 Day) & Site Selection Visit (1 Day)
Site Initiation Visit (2 Days)
Site Monitoring Visit (1 Day)
Site Closure Visit & Errors, Misconduct & Fraud (1 Day)

• Establishment, regular monitoring and closure of a clinical study at a selected investigative site.
• All site visits include preparation for the visit, visit activities, administrative and logistical follow and reviewed at each stage.
• Practical exercises to give you hands on experience to simulate in actual situations that you would encounter as a CRA.

For more information or to discuss clinical research associate training – (CRA) please contact us directly.