Advanced Course for Clinical Research Associates (CRA)

Description
General

If you are a senior CRA and want to level-up your project insights, zoom out and get grip on the bigger picture of clinical site and project management, then this course is waiting for you.

This training is a full-day course to cover high-level aspects of clinical projects. Topics that will be covered include: Prioritising Activities, the Monitoring Plan, Improving Investigator Selection, Best Practise for Site Initiation Visits, Subject Recruitment and Retention, Site Management, Monitoring Visit Reporting, Post-Visit Study Management: Visit Follow-Up and Tracking, Protocol Deviations – How to document and react upon, Audit/inspections: How to be prepared and how to react, Risk assessment – What can we do.

At the end, you will receive a certificate and the course hand-outs.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Know how to tackle on site and remote monitoring activities
  • Select the right investigator for your trial and help the site with proper patient recruitment
  • Improve your documentation abilities of your monitoring activities
  • Be prepared for audit or inspections, know what to do and how to behave
  • Know how to assess risks on protocol, site and study level
  • Manage your site throughout the trial
Intended audience

Advanced Level
Demonstrates advanced skills and knowledge and the ability to teach, coach, or supervise others. Consistently applies critical thinking and problem solving.

Trainer
Gerald Van Roey
  Gerald Van Roey MPhEd had over 10 years of experience in Clinical Operations before switching his career into the training business in 2009. He has worked as trainer and managing director for the ECCRT, European Centre for Clinical Research Training before starting his own company in 2015. As a clinical monitor he performed more than 40 studies in areas including pharmaceutical, biotechnology and medical devices in all stages of clinical development. In his previous career he implemented different trial tools and mentored many junior CRAs. His extensive knowledge and background serves him as a manager and trainer for different courses. In his trainer function he has coached over 1000 clinical research professionals and has delivered courses in 14 different countries.