Advisor Clinical Trials
Since October 2018
evaluation of submission packages to the Ethics committee (academic trials)
contracts: set-up + finalization
Evaluation of submission packages to the Ethics Committee (academic trials)
Contracts: set-up + finalization
TravelDecember 2017 --- September 2018
travelled in south-america for 10 months.
Study Start-up SpecialistMay 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 NurseNovember 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 associateOctober 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.
ProactivityAdaptabilityAssertivenessAttention to detailCoordinationEfficiencyIndependenceOptimismProblem solving
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
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
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