Sophie PAUMEL
84210 Pernes les Fontaines - France
E-mail : s.paumel@clinical-research.fr
Freelance Senior Clinical Research Associate (CRA)
Post-graduate in cellular biology – CRA training – 12 years of job experience
COMPETENCES
Involvement in national and international clinical trials (phase I, III and IV, hospital and liberal practices with GP and specialists)
Clinical Trial Authorisation preparation and submission to the French Ethic Committee / Competent Authorities
Organization of investigator’s meetings (protocol presentation, GCP training, results presentation..)
Pre-trial, initiation, monitoring and close-out visits
CRO supervision
JOB EXPERIENCES
From Sep 2010 - Freelance senior Clinical Research Associate
2009- 2010 - ICON Clinical Research: home-based senior Clinical Research Associate
Psychiatry- Paediatric study (Lilly): submission, selection, initiation, monitoring visits for phase III study
Neurology (Lilly): contract negotiation, initiation visits, presentation for investigator’s meeting
2006 – 2007 - I3 Research: home-based Senior Clinical Research Associate
Psychiatry (Sanofi Aventis, Janssen-Cilag, Bristol Myers Squibb): selection, initiation, monitoring and close-out visits for a phase III study
2002 – 2005 - MAPI: home-based Clinical Research Associate
Psychiatry (Lilly): selection, initiation, monitoring visits for a phase IV study
Neurology (Sanofi Synthelabo): monitoring, phase IV
Oncology: (Astra Zeneca) : monitoring for compationate use
1999 – 2001 - D. C. I.: Clinical Research Associate
Nephrology (Amgen): monitoring as home-based CRA (South-East of France) for a phase III study
Psychiatry (Lundbeck): selection, initiation, monitoring visits for international phase III study
Dermatology (Roche Nicholas):
Phase I: CRF design, preparation of Ethic Committee submission, organisation of investigator’s meeting
Phase III: monitoring and close-out visits
Infectiology (Glaxowellcome): investigator’s selection and initiation visits
1998 - 1999 - Merck, Lipha Santé: Clinical Research Associate
Oncology: international study, phase III, site selection, collection and preparation of regulatory documents.
Cardiology: phase IV study, initiation, monitoring, and close-out visits. CRO supervision
Pharmacovigilance reporting and case follow-up reporting to the national authorities
EDUCATION
1998 CRA training at the “Sup-Santé Institute” (Paris)
1993 Post-graduate in cellular biology and microbiology (University of Marseille - France)
MISCELLANEOUS
Knowledge of Microsoft Office (Word, Excel, PowerPoint)
English: operational
Feasibility study for establishment of clinical center of investigation at the French hospital of Carpentras in collaboration with the Central Institute for Clinical Investigations (C.I.C.I., Sophia-Antipolis, France).
