2011 - maintenantIn charge of activities GCP-PAI "Good Clinical Practices - Pre-Approval Inspections" and ensure proper compliance overall record of the study for inspection agencies following the submission of new IND.
- Review reports of monitoring visits, implementation and monitoring of corrective actions
- Verification / compilation of documentation required for inspection (eg trainings logs)
- Monitoring of corporate audits, site investigators and CROs by participating in the development of responses to the comments of the auditors and ensuring that corrective actions have been implemented on the sites audited.
- QC of CSF and LSF
- Preparation of maps and PAI response elements necessary for the presentation of the study for inspection, according to the FDA Compliance Program Guidance Manual
Hays Pharma outsourced
- CRA
2008 - 2011Conduct pre-study, initiation, monitoring and close-out visits in accordance with ICH,GCP and EU regulations
Maintenance of Trial Master Files.
Coordinate and conduct feasibility studies.
Recruit investigators.
Perform IRB, Regulatory Authority and Data Protection submissions Local and International Clinical trials in phase, II, III, IIIb, IV
Management for local NIS, Post marketing clinical trials and RMP projects
Site management, track progress of site performance and initiate actions to ensure study objectives are achieved.
Conduct co-monitoring visits with CRAs or with external auditor.
Audit and selection qualification of CROs or others vendors
Creating databases, participating to elaborate an e-CRF, writing and creating work instruction in accordance with internal Procedures
Work in multiple scientific areas such as Respiratory, Pain,Cardiology, Hepatology and Surgery
SanofiPasteur
- Research associate
Lyon2006 - 2008Global Clinical Immunology department, Immunochemestry platform. Sanofi-pasteur,Swiftwater( PA) USA.
Research Associate/: Implemente and validate an ELISA test to quantitate the antibodies in human sera. Responsible for performing routine clinical testing for vaccine products by use of the ELISA methods, data analysis. Knowledgeable in SQLIMS, Softmax Pro, Microsoft Word, Excel and Powerpoint. Compliant with cGMPS’s/ GLP’s, follows aseptic technique and good documentation practices. Communicates to technicians of any sudden or abnormal alterations in the daily operations in the laboratory.
Experience working in BioSafety Level 2 and 3 Laboratories.).Work on Luminex technical
