Experienced GCP-Auditor for Investigator Site Audits in Japan (m/f)

REFERENZNUMMER:

292764/9

IHRE AUFGABEN:

-Two audits of the investigator site have to be conducted
-Conduct interview with the investigator and staff to obtain information on how they are recruiting subjects, obtaining informed consent, implementing the protocol and documenting the results
-The investigator's site files have to be reviewed and a sample of subjects will be selected for source data verification
-The storage, documentation and management of the investigational products have to be reviewed routinely
-A tour of the facilities has to be conducted as well as documentation for equipment being used in the study has to be checked
-Preparation of the investigator site audit, including site specific essential documents

IHRE QUALIFIKATIONEN:

-Certificated ICH GCP auditor / Senior Auditor for ICH GCP
-Experience in ethical norms, laws (physician law and drug law) and regulations
-Knowledge regarding investigator site audits in Japan
-Knowledge of relevant local laws, ethical norms and regulations
-Good knowledge of Japanese
-Profound experience regarding audits in Japanese investigator sites

WEITERE QUALIFIKATIONEN:

Auditor