Research. With a successful monitoring. With me.

Today Clinical Monitoring is more than only source data verification.

 

In fact CRAs (Clinical Research Associates) are being Site Manager, who has to supervise on site the conduct of the clinical trial apart from the source data verification.

To fulfill the requirements of a clinical trial the adhere to timelines and milestones is inalienable. Therefore strong organizational skills are required. 

The "corporate" conducting of a trial should be the target of the study sites and the CRA - to these belongs a closely contact with the site, a solid confidence base, good reachability, constantly readiness to help and competence regarding the trial protocol, Good Clinical Practice and the national and international law. Scientific and medical knowledge is obligate - furthermore ultimate expertise in interpersonal communication.

This is where my contribution takes place.

For example:

  • Choice of suitable study sites

  • Compiling of individual manuals to carry out the monitoring

  • Selection visits

  • Initiation visits

  • Routine visits

  • Close out visits

  • TMF-compilation and/or update

  • Briefing of study centres regarding the study and the eCRF

  • Comparison of study files with source data

  • Query management

  • Monitoring of SAE documentation

  • Ensuring of filing in accordance with GCP

  • Prompt reports after every visit

  • Preparations before audits