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