Clinical Research Training for Senior CRAs (Milan) Back
In this 2-day course you will learn how to optimise your monitoring methods and skills, how to solve recruitment and 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 2-day 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.
- To refine your 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 protocols and CRFs
- To provide the fundamentals of clinical report writing
- To explain the elements of efficient site management from start to finish
- To develop soft skills for improving communication and teamwork
- Importance of international research - the role of the ICH process
- Update on the implementation of the EU Clinical Trial Directive
- Protocol development CRF development & Electronic Data Capturing
- Quality systems and audits
- How you can help the study to the point of the final report
- Soft skills training: the win-win approach for communicating and teamwork
- Improving recruitment and site management
- Informed Consent
- Audit findings
Certificate of Comprehension
Everyone who participates in our courses receives a certificate of attendance. In addition to this we are now able to offer a Certificate of Comprehension for a growing selection of our courses, including this Clinical Research Training for Advanced CRAs course.
Participants receive these certificates after completing a one hour test and achieving a test score of at least 70%. The test is composed of multiple choice and case study questions. Participants are allowed to consult their course notes and the extensive training material provided.
Who should attend?
- CRAs who want to set new objectives in their career.
- This course will also be beneficial to people working in other areas such as clinical data processing, biostatistics and regulatory affairs.