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Experiences

Current Experience

  • Clinical Research Consultant

    London, United Kingdom
    Since November 2017

    Founder of xera consultancy ltd. 

    Founder of Xera Consultancy Ltd. 

Past Experience

  • Clinical Research Associate (CRA) Istanbul, İstanbul, Turkey

    June 2015 --- March 2017

  • Clinical Trial Assistant (CTA) Istanbul, İstanbul, Turkey

    April 2014 --- October 2014

Personality

Self Assessment :
AdaptabilityApproachabilityAttention to detailCommunicativeCreative thinkingFlexibilityIndependenceInterest in knowledgePerspectiveSelf-confidenceTrust

Knowledge

Self Assessment :
Biochemistry21 CFR Part 11Adverse Events (AE)Analytical techniquesBioinformaticsBiologyCardiologyCardiovascular diseasesClinical Data Management (CDM)Clinical monitoringClinical operationsClinical trial audits and inspectionsClinical Trial Management System (CTMS)Clinical trialsComplianceCRFeCRFElectronic Data Capture (EDC) Enzyme AssaysForecastingGeneticsGood Clinical Practice (GCP)Good Manufacturing Practice (GMP)HematologyICH guidelinesInfectious diseasesInformed Consent ProcessIVRSLife SciencesmanagementMicrosoft OfficeOxidative stressPharmaceutical ResearchPhases of clinical development (phase I to IV)Project CoordinationScientific WritingSerious Adverse Event (SAE)Start-ups

Skills and Expertise

Self Assessment :
Analytical skills Monitor a clinical studyAssist study siteCalculate trial timelinesCapture data on source documentsClinical data collectionConduct close-out visitsComplete case report form (CRF)Conduct studiesConduct the trialCoordinate logisticsCoordinate projectsCreate clinical documentsData entryData verificationEnsure good clinical practice (GCP)Follow up projectsForecasting of drug productIdentify sitesInterpret scientific dataLiaise with doctors and other professionals throughout the studyManage clinical trial files/documentsMonitor dataproject managementRead medical literatureReport serious adverse events (SAE)Respond to audit findingsReview clinical study reportsRetrieve study documentsReview dataReview exclusion criteriaReview inclusion criteriaReview informed consent processSchedule trial visitsTrain off site staffTrain on site staffTranslate clinical research concepts into specific objectivesUpdate Clinical Trials Management System (CTMS) Verify datawrite and maintain clinical evaluation reportsWrite clinical evaluation reportsWrite final reportsWrite papers

Education

  • Master of Science in Bioengineering from Sabanci University in 2014
  • Bachelor in Bioengineering from Sabanci University in 2011

Training and Certification

  • ICH-GCP in 2016 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    Turkish
    Native
    English
    Professional Proficiency
    Spanish
    Elementary Proficiency
    German
    Elementary Proficiency

Work Preferences

  • Notice Period:
    6 weeks
  • Positions I am interested in:
    Clinical Research Associate (CRA) Clinical Development Consultant Clinical Research Consultant Clinical Trial Assistant (CTA) Clinical Trial Specialist (CTS) Regulatory and Start-Up Specialist Translator
  • Locations I am interested in:
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position
    BrightOwl freelancer :    6 Hours per week
  • International:
    Yes

Publications

    Expert has 2 publications (Will be avalible with full profile)

Area / Region

London, United Kingdom

Others

Driving License
  • Yes

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