Clinical Research Training for Senior CRAs

 

Clinical Research Training for Senior CRAs

Clinical Operations Courses
Part of Star Programme

In the course of this 2-day training you receive added knowledge on the responsibilities of a more mature monitor. You learn how to review protocols and informed consents, how to boost recruitment and manage your sites; and how to better communicate with hospital staff.

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1 100,00 €
Testimonials
  • Full description & trainer
  • Programme highlights
  • Learning objectives
  • Workshops & extras
Full description

In this two-day course, you will learn how to optimise monitoring methods and skills, how to boost recruitment and how to solve site management issues and gain insights into protocol and CRF development, quality systems and audits. A detailed look at ICH-GCP and updates on the EU directives will also be given and a half-day session on communication skills will address issues such as how to reach a win-win situation with study site personnel and how to work within a team.
This course has been specifically designed for people with at least 2 years’ experience as a Clinical Research Associate (CRA) and who want to set new goals and objectives in their career.

Who should attend?

Clinical Research Associates (CRAs) with min 2 years experience, who want to set new objectives in their career and/or experienced people working in clinical data processing, biostatistics, regulatory affairs, etc.

Trainers
  • Importance of international research – the role of the ICH process
  • Update on the implementation of the EU Clinical Trial Directive
  • Protocol development and Final Study Report
  • CRF development & Electronic Data Capturing
  • Quality systems and audits
  • Communication skills (content: see soft skills training part in this prospectus)
  • To refine knowledge of ICH-GCP, quality systems and audits
  • To provide an update on EU Clinical Trial Directives
  • To highlight important elements in the development of protocol and CRF
  • To explain the elements of efficient site management from start to finish
  • To develop soft skills for improving communication and teamwork
Workshops
  • Improving recruitment and site management
  • Informed Consent
  • Audit findings
Extra's
  • Comprehension Test
  • All participants receive a copy of the book “Best Practice for Clinical Monitoring’ - by Mr Gerald Van Roey (Publisher: PharmImage, 2011)