Mes compétences :
SAEs management
Pharmacovigilance
Microsoft Office
Entreprises
PPD
- ARC II
2016 - maintenant
Georges Pompidou Hospital
- Clinical Research Associate
2013 - 2016Job Functions:
* National Multicentric, Randomized, Open-label, * Ensure patient safety, quality of data and adherence
Phase III and IV interventional or not Studies. to the protocol in compliance with SOPs/ GCP and
* Assist project manager in regulatory submission to local regulatory.
authorities and ethics committee making. * Drug Safety and Epidemiology: SAEs management
* Creation of study documents and standard and follow-up.
operative procedures. * Planning and coordination of critical events
* Preset investigation centers. adjudication committees. ;
* Site Initiation visits and hospital staff training. * Queries management (edition and validation). ;
* Planning meetings for investigators. * Supplies checking (biology, pharmacy services). ;
* Monitoring visits: paper and electronic Case * Audit preparation (internal and external).
Report Form (CleanWEB and RedCap).
* Close out visit, data archiving.
Hepatobiliary Centre
- Clinical Research Associate
2013 - 2013: Clinical Research Associate - Hepatobiliary Centre - Paul Brousse Hospital -
Biologic simple management, assistance in data collection in consultation, filling in report forms (paper and
electronic) and databases; participation in CRAs monitors visits.
Capsis
- Technicien Microbiologique
LES ULIS2011 - 2011Analyses microbiologiques des eaux industrielles
