As a Clinical Research Associate at a large CRO, Katrien served as contact between Investigator and Sponsor and worked according to several different sponsor SOPs. She gained a broad working knowledge of all phases of clinical trials, from feasibility to study closure.
During 4 years, she specialized in the start-up phase of clinical trials and learned to manage several projects simultaneously and deliver quality work by well-defined tight deadlines. She took on a more coaching role and provided on-going training to other clinical research associates.
As CRA - Clinical Study Coordinator on a national trial, she gained experience with the set-up/ development of essential documents for a clinical trial, organized work flow with third vendor providers and managed study budget.
She was praised for her team spirit and is well known for her high quality work.
Senior Clinical Research Associate - Clinical Study Coordinator Aalst, Belgium
Since August 2014
Outsourced through Novellas Healthcare - Managing + conducting all aspects of (inter)national clinical trials - Responsible for contract negotiations with sites and third party vendors - Managing study budget of national clinical trial - Preparing study documents (protocol, ICF, study manuals etc)
Senior Start-up CRA
January 2010 --- January 2014
- Performing and coordinating identification and selection of qualified study sites - Overviewing start-up phase of an international study as lead Start-up CRA - Feasibility Coordinator: responsible for providing and/or performing quality check of proposed feasibility site lists and coordinating feasibility process in Belgium - Accompanier: Authorised to conduct Performance Assessment Visits to provide ongoing training, evaluation and development of other CRAs
Clinical Research Associate (CRA)
January 2007 --- January 2010
January 2006 --- January 2007
Attention to detailStrategic thinkingService orientedProblem solvingPerspectiveInterest in knowledgeIndependenceFlexibilityCoordinationCollaborationAuthenticitySociability
Clinical monitoringCTMSGood Clinical Practice (GCP)Infectious diseasesPhase IIPhase III
Skills and Expertise
Build and manage the Trial Master File (TMF) Interact with nurses Interact with physiciansAssess site feasibilityCoachConduct the trialCoordinate logisticsCoordinate with the ethics commiteeManage Clinical Trial Management System (CTMS)
Master's Degree in Biomedical Sciences, General from Ghent University in 2006