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Summary

profound understanding of Clinical research methodology and regulations excellent presentation and Communication Skills ability to think independently and take initiative excellent Project Management skills accelerated development of study monitory plan which brought about regulatory and operation harmony within the company compiled a series of workable protocols that worked closely with study Documentation procedures including biographical materials and approved consent forms highly skilled in developing project plans and schedules hands on experience in tracking projects and reporting on budget and project status in depth knowledge of evaluating system solutions and preparing reports for safety monitoring committees

Experiences

Current Experience

Past Experience

  • Continuous Study

    June 2014 --- October 2014

    Clinical Research Associate; focus, ich gcp Training, Training for Clinical Research Associate; focus ich gcp Training includes; Drug Development, Clinical trials overview, legal basis, mpg, obligations of the test center, gcp- documents, registration authorities, Documentation and Data Management, Pharmacovigilance, audit and inspections.

  • Training

    June 2013 --- October 2013

    Clinical research Training focus; ethical issues in human subject research; roles and responsibilities of the Investigator; roles and responsibilities of the institution; regulatory issues e.g. FDA guidance regarding Clinical trials, ich guideline for good clinical investigators and mass media.

  • Project

    April 2011 --- July 2011

    Image Processing in Cell tracking force; (image modeling) with mat-Lab and image j; particle tracking Strategy to determine cellular traction force

  • Intern

    November 2010 --- February 2011

    radiology Image Processing with mat- Lab

  • Student

    September 2010 --- January 2011

  • Postgraduate Student

    October 2008 --- November 2009

    study postgraduate in nano- Biotechnology technische University, kaiserslautern

  • Lab.

    January 2008 --- January 2009
    Biochemistry / Laboratory Laboratory work in the department cellzome.

  • Project Assistant

    January 2007 --- February 2008

  • Lab. Project

    January 2007 --- February 2008

    Research of Cell cultures: glioblastoma cells, immortalization, Cell counting etc. immuno-histochemical methods: frozen- section histological sections, staining for elastic fibers in histological sections, molecular biology: RNA- isolation rt-PCR, etc. animal Experiment subcutaneous tumor injection, determination of tumor growth in nude mice highly skilled in developing project plans and schedules, hands on experience in tracking projects and reporting on budget and project status, in depth knowledge of evaluating system solutions

  • Bachelor Student

    July 1996 --- July 2001

    bachelor study in Biochemistry abia University uturu (nigeria)

Personality

Self Assessment :
EfficiencyAnalytical thinkingCompetitivenessCritical thinkingInterest in knowledgeProblem solvingTrustSelf-confidenceKindnessOptimismFlexibilityCoordination

Knowledge

Self Assessment :
BiochemistryBiotechnologyCancerCell CultureClinical monitoringClinical researchData Management Medical devicesClinical Data Management (CDM)Clinical trialsFDAGCPGood Clinical Practice (GCP)ICH GCP guidelinesICH-GCPImmunohistochemistry (IHC)MATLAB (matrix laboratory)MicroscopyMonitoring Study ProgressNew Drug Application (NDA)oncologyPCRPharmacodynamicsPharmacokineticsPharmacovigilancePhase IPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)ProtocolQuality Assurance (QA)Radiation oncologyRandomization SystemsRegulatory affairsSerious Adverse Event (SAE)SOPStrategic PlanningWriting Study Procedures and SOPsInformed Consent Documents
LinkedIn Assessment :
Microsoft OfficeMicrosoft ExcelResearchCustomer ServiceMicrosoft WordPublic SpeakingHealthcareStrategic PlanningmanagementOutlookClinical research

Skills and Expertise

Self Assessment :
Data analysisDesign case record form (CRF)Design trial master file (TMF)Select investigatorsSchedule trial visitsTrain on site staffVerify dataWritten presentationValidate dataSupervise trial suppliesReview exclusion criteriaReview inclusion criteriaReview clinical study reportsRegulatory submissionsRegulatory documentationPlanning clinical studiesMonitor a clinical studyMonitor clinical trials Manage Quality Management System (QMS) documentationManage Clinical Trial Management System (CTMS) Labeling compliance with local regulationsInitiation visitEnsure good clinical practice (GCP)Distribute trial suppliesDevelop ICH/GCP compliant processesDevelop clinical trial protocolsDevelop clinical strategy etc. necessary in monitoring and drug accontability. Create SOPs Develop clinical trial protocols Develop protocols Monitor a clinical study

Education

  • Clinical Research Associate in Clinical Research from Pharmaakademie in 2014
  • Master in Biomedical engineering from Heidelberg University in 2011
  • Master's degree in Biomedical Engineering from universitätsmedizin Mannheim/Heidelberg in 2011
  • Post Graduate in Nanobiotechnology from Technische University Kaiserlautern Germany in 2009
  • Postgraduate in Nano-biotechnology from Techni. university Kaiserslautern in 2009
  • Bachlor of Science in Biochemistry from Abia State University in 2001

Training and Certification

  • Clinical Research Associate PharmaakademieMannheim in 2014 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Native
Afrikaans
Native
German
Professional Proficiency

Work Preferences

  • Notice Period:
    1 week
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Germany

Others

Driving License
  • Yes

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