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Summary

perform selection, initiation, monitoring and closure visits at Investigator sites according to project schedule. monitor activities at Clinical study sites to assure adherence to gcp, ich, sops, and study protocols. prepare site visit reports and telephone contact reports. participate in the start-up process including reviewing protocols, reviewing crfs, preparing Informed Consent forms, developing study documents, organizing and presenting at Investigator meetings conduct study drug inventory perform adverse event and serious adverse event reporting and follow-up

Experiences

Current Experience

  • Clinical Research Associate (CRA)


    Since March 2015
    perform selection, initiation, monitoring and closure visits at Investigator sites according to project schedule. monitor activities at Clinical study sites to assure adherence to gcp, ich, sops, and study protocols. prepare site visit reports and telephone contact reports. participate in the start-up process including reviewing protocols, reviewing crfs, preparing Informed Consent forms, developing study documents, organizing and presenting at Investigator meetings conduct study drug inventory perform adverse event and serious adverse event reporting and follow-up Perform Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols. Prepare site visit reports and telephone contact reports. participate in the start-up process including reviewing protocols, reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings Conduct study drug inventory Perform adverse event and serious adverse event reporting and follow-up

Past Experience

  • attaché de recherche clinique

    July 2012 --- February 2015
    complétion des crf arc dans plusieurs services : oncologie, cardiologie, réanimation. prise en charge de toutes les tâches délégués par l'investigateur. notifications des eig à l’investigateur suivi des patients et documentations de tout les ei, eig et effets indésirable suivi logistique des essais création et mise à jour des outils de travail, rédaction des documents de la recherche

  • Medical Sales Representative

    January 2008 --- December 2011
    communiquer au médecins une information de qualité développement et entretiens des relations avec les professionnels de la santé

Personality

Self Assessment :
AdaptabilityAttention to detailCommunicativeCoordinationFlexibilityInterest in knowledgeOrganizationProblem solving

Knowledge

LinkedIn Assessment :
Recherche cliniqueBonnes pratiques cliniquesCardiologieFormationMRechercheServices de santEssais cliniquesSecteur pharmaceutiqueHOncologie

Skills and Expertise

Self Assessment :
Analytical skills Design case record forms Interact with physicians Monitor a clinical studyAct as the main line of communication between the sponsor and the investigatorAdverse event reportingAssess site feasibilityConduct site initiationReport serious adverse events (SAE)Review monitoring reportsSchedule sponsor monitoring visitsSchedule trial visitsSelect sitesSet up a clinical studyWork with coordination and data management teams

Education

  • attaché de recherche clinique in from Ecole SupSanté in 2012
  • dipolome national de visite medical in from GEMS Paris la defense in 2008
  • master de biochimie in from Université des Sciences et Technologies de Lille (Lille I) in 2003

Training and Certification

  • clinical research in 2012 Training
  • medical sales representative in 2008 Certification
  • biochemistry master in 2003 Certification

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency
German
Elementary Proficiency

Area / Region

Lyon, France

Others

Driving License
  • Yes

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