I’m not only interested in how the human body works, but also science and technical matter satisfy my eagerness to learn. With a positive and calm mindset, I’m able to solve problems in a creative way. Besides, finding the right balance between attention to protocol detail and listening to the needs of site personnel helps me to strike the golden mean for all stakeholders.
Those skills, in combination with my work experience, enable me to elaborate myself as a trusted person by collaborating with all parties to achieve a common goal.
Senior Clinical Research Associate (CRA) Vilvoorde, Belgium
Since September 2014
Enumeration of my tasks in the department Real-World & Late Phase Research (Phases IIIb and IV therapeutic areas: Multiple Sclerosis, CAPS, Diabetes, Melanoma, Ulcerative colitis, Alzheimer, Thrombosis): • Start-up processes: budget negotiations, customizing (and translating) informed consent forms, EC submissions. • Performing (remote) site selection, initiation, monitoring, and close-out visits. • Filing documents appropriately in the e-TMF or SharePoint. • Develop therapeutic knowledge in the area of expertise. • Mediating the site payments by processing the invoices. • Collaborating with other functional groups (site managers, and site mgmt. lead) • Remote communication with sites, study team, and line manager. • Multitasking between different projects, according to priority. • Timely reporting of billable hours, corresponding with each project. • Mentoring new colleagues, and providing assistance to less experienced CRA’s.
Attention to detailCollaborationCreative thinkingCuriosityFlexibilityOptimismProblem solvingSelf-discipline
TeamworkStandard Operating Procedure (SOP)Serious Adverse Event (SAE)Safety reportingRheumatologyQuality ManagementProtocolPowerPointPhase IVPhase IIIPhase IIPCROutlookMultilingualMicrosoft WordMicrosoft PowerpointMicrosoft ExcelMicrosoft OfficeInformed Consent ProcessInformed Consent Documents
Skills and Expertise
Interact with nurses Interact with physicians Monitor a clinical studyAdverse event reportingConduct close-out visitsComplete case report form (CRF)Identify and provide training to trial team and associated staffInformed consent process
Master in Management from K.U. Leuven in 2010
Master in Biomedical Sciences from K.U. Leuven in 2009