Mes compétences :
Biotechnologies
Coordination
CRO
Études cliniques
GCP
Guidelines
ICH
monitoring
Entreprises
Chiltern International
- Clinical Team Leader/ Clinical Project Leader pour Genzyme - Sanofi
Slough2012 - maintenant
Chiltern International
- Senior Clinical Research Associate pour Genzyme
Slough2011 - 2012
DOCS
- Senior Clinical Research Associate pour Johnson&Johnson
2010 - 2011
CLINACT
- Clinical Research Associate trainee
2006 - 2006- Managed two epidemiological studies.
- Monitored by phone: sites selection, initiation, follow-up.
- Managed essential documents of the studies: Sites financial contracts, patient questionnaires, and investigators invoices.
- Managed assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
-Transversal project: “Psychiatric specificities in Clinical Research”
Selected Psychiatrists involved in Clinical Research.
Performed visits and interviews supported by a questionnaire written by the team.
Reported to project team all minutes.
Prepared the report.
Gave a presentation in English.
I3 Research
- Clinical Research Associate
2006 - 2010- Performed routine site visits, including pre-study, initiation, interim, and closeout visits. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance.
- Managed assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
- Reported to company project team, client, and site personnel any findings noted at monitoring visits.
This was accomplished by completion of monitoring reports and follow-up letters within the project- specific timelines.
- Trained study team members on a specific electronic CRF application
- Participate in vendors set-up activities
- Maintained project tracking systems of activities, subject and site information.
- Participated in feasibility studies.
- Participated in regulatory and contract set-up activities
- Participated in company-required training programs.
- Performed necessary administrative functions (e.g., tracking of expense reports, time and attendance).
- Performed other duties as assigned.
Aster Céphac
- Study Nurse
2005 - 2005- Phase I only
- Reported data in CRFs in collaboration with
investigators.
- Performed ECG, holters.
-Took blood pressure and blood samples.
