Freelance Clinical Research Professional Geel, Belgium
Since January 2011
Freelance Clinical Research Professional: start up, monitoring and managing Medical Device studies (neuromodulation, vascular disease, orthopaedics).
Used to work in a start up company environment, used to work in European environment.
Field clinical support: surgeon trainings and technical support in operation theatres, Europe.
Experienced study coordinator at clinical site.
Clinical Research Manager Brussels, Belgium
May 2002 --- January 2011
Clinical Research Associate, Clinical Project Manager and Clinical Research Manager.
Managing an international team of monitors (project management, line management).
Training, proctoring surgeons in the operation theatre / radiology suite across Europe.
Clinical Research Associate (CRA) Brussels, Belgium
November 2000 --- May 2002
Clinical Research Associate, monitoring medical device trials Belgium and Germany.
FlexibilityDiligenceCreative thinkingProblem solving
Medical devicesBudget ManagementBudget NegotiationCardiovascular diseasesClinical operationsClinical Study DesignClinical trial managementDesign and tracking systemsEthics submission and approval processGood Clinical Practice (GCP)Interventional RadiologyOperating RoomPatient Screening and RecruitmentProject ManagementTechnical SupportSupervising CRAsStart-upsSafety reportingRegulatory submissions
Skills and Expertise
Build and manage the Trial Master File (TMF) Design case record forms Develop clinical trial protocols Guide students Interact with nurses Monitor a clinical studyAdverse event reportingAttend steering committeeAttend investigator meetingCoachAssist with proceduresCollaborate with principal investigatorCollaborate with project teamCreate study documentsDevelop study budgetEnsure good clinical practice (GCP)Ethics committee submissionsFollow-up of internal auditsInteract with CROsIdentify investigatorsManage Clinical Trial Management System (CTMS) Manage contractors Manage study supplyOrganise meetingsPrepare internal auditsPrepare regulatory documentsPresent clinical resultsProvide trainingRead medical literatureSelect contractors Set up a clinical studyShipment of biological specimen
Bachelor in nursing from Sint Aloysius, Lier in 1994