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Summary

positive, motivated and dynamic Biomedical Scientist with previous experience in Clinical trials (study Coordinator, study start-up specialist and medical affairs associate) is looking for a new challenge as a Clinical Research Associate.

Experiences

Current Experience

  • Advisor Clinical Trials


    Since October 2018

    temporary replacement. 

    evaluation of submission packages to the Ethics committee (academic trials)

    contracts: set-up + finalization

    Temporary replacement. 

    Evaluation of submission packages to the Ethics Committee (academic trials)

    Contracts: set-up + finalization

Past Experience

  • Travel

    December 2017 --- September 2018

    travelled in south-america for 10 months. 

  • Medical Affairs Associate

    June 2017 --- December 2017

    Project Management of Investigator initiated studies, medical need programs and compassionate use programs.

  • Study Start-up Specialist

    May 2015 --- December 2017

    responsible for all study related start-up tasks from ec/ha submission until study initiation (creation of country specific icfs, collection of all necessary documents for submission to Ethics committee and Health authorities, close contact with sites to prepare them for study initiation, resolve issues before study starts).

  • Clinical Research Nurse

    November 2012 --- June 2014

    commercial study tasks: study initiation – completing site feasibility form (in correspondence with pi) – attending Investigator meetings – correspondence with trial bureau and ethical committee – Patient Recruitment and follow-up - handling and shipping of Lab samples – completing edc, solving queries – ae and sae reporting – storage and temperature management of investigational product – filing of study documents – follow-up on study payments according to contract – main contact person for sponsor – study close-out and archiving.

    academic study tasks: preparing necessary documents for study submission – correspondence with trial bureau and ethical committee – submitting addenda for science)" rel="nofollow">Protocol adjustments.

  • Research associate

    October 2011 --- October 2012

    after i graduated, i got the opportunity to start a phd at the Endocrinology department of the University Hospital ghent. i soon realized that this was not the Career path that i wanted to follow. therefore, i decided to stop working on this project in mutual understanding with my promotor and co-promotor. they gave me the opportunity to start working as study Coordinator.

Personality

Self Assessment :
ProactivityAdaptabilityAssertivenessAttention to detailCoordinationEfficiencyIndependenceOptimismProblem solving

Knowledge

Self Assessment :
Diabetes Scientific writingCardiologyClinical Data Management (CDM)Clinical trialsData entryElectronic Data Capture (EDC) Endocrinology and metabolismEndocrinologyEthics submission and approval processGCPHospitalsICH GCP guidelinesInformed Consent ProcessPatient Screening and RecruitmentPhase IIIPhase IVPowerPointProtocolSearch literature on clinical trialsSerious Adverse Event (SAE)Informed Consent Documents

Skills and Expertise

Self Assessment :
Analyze data Control data Interact with nurses Interact with physicians Search literature on clinical trials Write papersAdverse event reportingCapture data on source documentsClinical data collectionCollaborate with principal investigatorCommunicate with investigatorCommunicate with sponsorComplete case report form (CRF)Conduct the trialContact potential subjectsControl dataCoordinate with the ethics commiteeCreate study documentsData entryDocument adverse eventsEnsure data consistencyEnsure good clinical practice (GCP)Ethics committee applicationEthics committee submissionsFacilitate sponsor monitoring visitsInitiation visitPatient recruitmentPlanning clinical studiesScreen patients

Education

  • Master in Biomedical Sciences from Ghent University in 2011

Training and Certification

  • Good Clinical Practice in 2013 Certification
  • Trained DXA and pQCT professional in 2013 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
French
Professional Proficiency
Spanish
Elementary Proficiency

Work Preferences

  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    FTE (100%)% FTE
  • International:
    Yes

Area / Region

België

Others

Driving License
  • Yes

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