Description
We are looking for an
Experienced GCP-Auditor for Investigator Site Audits in Japan (m/f)
Reference: -en
Start: 02/16
Duration: 3 MM+
Place: in Japan and remote
Branch: Pharmazeutische Industrie
Your tasks:
- 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
Your qualifications
- 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
Skills:
- Auditor
Keywords: GCP Japan Japanese Investigator Sites