Role: Clinical Study Coordinator

Theme:  Clinical Research

Location : CBRS, 2nd floor, Department of Pharmacology, Toxicology, and Pharmacovigilance, Office B21

Phone number: 05 55 05 61 40 (secrétariat) puis poste 52384

Email address: helene.roussel@chu-limoges.fr

Research

Clinical Study Management:

  • Responding to project calls
  • Writing/coordination of documents (protocol, Case Report Form, patient information leaflet, newsletter, reports) for a clinical study
  • Developing an initial budget and monitoring
  • Preparing and following up on regulatory files (Ethics Committee, ANSM, CNIL)
  • Setting up the study at investigator sites and monitoring
  • Logistical management of biological samples and specimen collection

Coordination of Analysis Services of the “Centralized Laboratory” Type
Management of the biological collection at the PTP site of the CHU de Limoges Biological Resource Center (CRBioLim)
Expertise/regulatory monitoring in clinical research

Career path

Since 2006 Clinical Study Coordinator, INSERM UMR 1248, Department of Pharmacology, Toxicology, and Pharmacovigilance at CHU de Limoges.
2005-2006 Clinical Research Associate, Phase II and III international oncology clinical trials at AstraZeneca, Rueil Malmaison.
2004-2005 Clinical Trial Coordinator for national and international nutrition studies at Danone-Vitapole R&D, Palaiseau.
2004 Clinical research training at Sup’Santé, Paris. Internship in the oncology department at AstraZeneca, Rueil Malmaison.
2000 à 2003 Research Engineer in Molecular Biology / Nitrogen Nutrition in Plants at INRA, Versailles.
1999 PhD in Sciences, specializing in Biochemistry and Molecular and Cellular Biology. Analysis of the transcriptome during plant/microorganism interactions at INRA, Dijon.