Mes compétences :
Clinical research
Clinical Research Associate
Entreprises
Quintiles
- Clinical Research Associate II
Durham2012 - maintenantWorking in phase II trial in Oncology (Non small cell lung Cancer) and other studies phase 1 and 3
- Monitoring Activities (Source Data Verification, queries resolution…) with 8-12 travels / months.
- Site selection, initiation, monitoring and close out visits at trials sites
- Writing site monitoring report
- Follow-up letter to the site staff
- Queries resolutions in collaboration with the Study Site Coordinator
- Audit report and writing CAPA (Corrective Action and Preventive Action plan)
Qualissima
- Clinical research associate
2010 - 2012Development of study documents: protocol, patient informed consent, CRFs, monitoring plan.
- Submissions to ethics committees and regulatory authorities
- Center selection and activation by phone contact
- Monitoring Activities with regular telephone contact
- Site selection, initiation, monitoring and close out visits at trials sites
- Maintain and review regulatory documents
- Writing report visits
- Queries resolutions
- Review to clinical report
