BrightOwl Loader Loading

Experiences

Current Experience

  • Senior CRA - Freelancer
    Since November 2008

    Services include:

    • All aspects of clinical trial conductance support e.g. ethics submissions and regulatory framework GE, SWI and AU
    • International monitoring experience (Sierra Leone, Poland, UK, Austria and Switzerland)
    • Study phase II-IV, NIS, IITs
    • Drug and Medical Device trials
    • GCP site staff and junior CRA training
    • SOP writing
    • Line management (LCRA) in national and international teams

Past Experience

  • Senior Clinical Research Associate (CRA)
    October 2007 --- October 2008

  • Senior Clinical Research Associate (CRA)
    May 2006 --- September 2007

  • CRA I
    January 2004 --- January 2006

  • Sales representative
    January 2000 --- January 2001

Personality

Self Assessment :
AuthenticityCommunicativeCreative thinkingFlexibilityIndependenceIndividualityOrganizationKindnessProblem solvingProactivitySelf-disciplineCharmTrust

Knowledge

Self Assessment :
Ethics submission and approval process Cell biology Diabetes Medical devices NegotiationAllergy and immunologyActions and modes of action of human physiologyBiologyClinical researchClinical monitoringClinical operationsClinical Study DesignClinical trial audits and inspectionsClinical trial managementCROCTMSDrug regulatory authoritiesDrug Safety and PharmacovigilanceEndocrinologyEnglishEnzyme-linked immunosorbent assay (ELISA)FDAFluorescence MicroscopyGel ElectrophoresisGeneticsGood Clinical Practice (GCP)GermanICH GCP guidelinesInfectious diseasesInformed Consent ProcessInternational RelationsMedical DevicesMolecular geneticsNew Drug Application (NDA)Oncology Clinical ResearchPCRPharmacokineticsPharmacodynamicsPharmacogenomics (study of genetic variation)PharmacovigilanceQuality Assurance (QA)Quality Control (QC)Quality of Life (QoL) outcomesRegulatory RequirementsReport WritingRheumatologyRT-PCRSafety reportingSalesSerious Adverse Event (SAE)TranslationUnderstanding of regulatory guidelines
LinkedIn Assessment :
Clinical monitoringEDCClinical researchGCPCROTherapeutic AreasRheumatoid ArthritisInfectious diseasesoncologyDiabetesRegulatory RequirementsVaccinesSOPICFImmunologyPatient recruitmentPainLife SciencesPain ManagementSOPClinical trialsLifesciencesICH-GCPClinical DevelopmentTherapeutic AreasCTMS

Skills and Expertise

Self Assessment :
Monitor a clinical studyAct as the main line of communication between the sponsor and the investigatorAssist study siteClinical data collectionCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with principal investigatorCollaborate with project teamCollaborate with medical team

Education

  • Diplom Biologin in Biology from Freie Universität Berlin in 1999
  • State Certified in Pharmacist Technician from Naturwissenschaftliche Akademie Prof. Dr. Grübler, Ins im Allgäu in 1992

Languages

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

Area / Region

Berlin-Mitte, Berlin, Germany - Worldwide

Others

Driving License
  • Yes