Stéphanie REGNAULT

En résumé

Entreprises

• Icon - Clinical Research Associate

  2011 - maintenant Principal Clinical research Associate:
  • Identify, select, initiate, and close-out appropriate investigational sites for clinical studies.
  • Monitor those sites in order to ensure that studies are carried out according to the study protocol, internal SOPs/WPs, applicable regulations and the principles of ICH-GCP
  • Prepare sites for audit/inspection
  • Manage studies with high number of vendors
  • Conduct accompanied visits with less experienced CRAs for training or authorization to conduct visits by themselves
  • Knowledge in French regulatory submissions, Investigators contract and hospital conventions, sites payments management
  Studies in following therapeutic areas: Major depressive disorder, Amyotrophic lateral sclerosis, Huntington's disease, Lymphoma/ chronic lymphocytic leukemia, Small cel lung cancer, Myeloma, Colorectal conditions, Gastrointestinal cancer, hemophilia
  
  
  
  Temporary CRA Managers secondment (Jul 2012- Jan 2013) :
  
  • CRAs on site accompanied visits coordination
  • CRAs training needs organization
  • CRAs metrics review
  

• PPD - Clinical research Associate

  2007 - 2011 Senior Clinical research Associate
  Studies in following therapeutic areas:
  Multiple sclerosis, Thyroïd cancer

• MDS Pharma services - Clinical Research Associate

  2005 - 2007 Studies in following therapeutic areas:
  Osteoporosis, Vaccines/pediatrics, Atrial fibrillation, prostate cancer (pain in bone metastasis)

Formations

Pas de formation renseignée

Réseau

• Bruno RAGAZZON

• Carla PAQUET

• Christophe MÉNARD

• Jean-Sebastien PY

• Lala NIANG

• Malika SIMERABET

• Nicolas LEROY

• Pierre HERIAUT

• Sylvie LEBEAU EYCHENNE

• Thi Thanh Mai NGUYEN