Clinical Research Associate (CRA)
Since November 2016
On field very quickly. Management of trials in phases IIb, III and IV, interventional and observational. Involved in studies with following pathologies: hepatology (NASH), dermatology (psoriasis), nephrology, rheumatology and endocrinology. Already performed : feasibility, contracts negotiations, SIVs, MVs, remote monitoring, phone contacts with sites (communication with study team: PI, SN, SC, financial department,...). Trainings: Junior CRA, Local Legislation, ICH-GCP trainings by ECCRT, SOPs.
October 2014 --- November 2016
Management of the first pharmacy of the start-up PharmaClic Medi-Market Group. Implementation of the hole structure needed to open a public pharmacy regarding the local legislation and the code of ethics. Recruitment of the team of the new pharmacy. Management of the inventory to be suitable with the needs of the patients/clients. Establishment of a customer service beyond reproach. In January 2015, integration of the internet site PharmaClic.be to the local pharmacy in Charleroi. Implementation of the operational and logistic management of the online sales site : team recruitment, reception of the orderings, preparing them according to the local legislation, sending them in the due time (48hrs). Establishment of the customer support in English, Dutch and French. Indeed the orderings are delivered in Belgium, Luxemburg, The Netherlands, United Kingdom, Germany, France, Italy and Spain.
Replacement Pharmacist under self-employed status
January 2012 --- September 2014
Replacements of every member of the pharmacy depending on the needs of the owner of the pharmacy. Performed in Brussels Area and Wallonia. Great degree of adaptation requested.
August 2005 --- January 2012
Subsequently doing replacements for the company in Brussels, then deputy of the Head Pharmacist in Brussels, and finally Head Pharmacist in the Province Luxemburg. Adjustment to every situation required by the different positions. Adaptation to the teams, the patients, the working habits, ... of each pharmacy I worked for. Insuring the continuity of the service when the Head Pharmacist was on leave. Achieving all the tasks due to a pharmacist in a public pharmacy: delivery to the patient in accordance with the physician's prescription, over the counter delivery, accompanying the patient in the better way to be compliant, controlling prescriptions, performing purchases for the pharmacy's stock, handling the pharmacy's staff (planning, holidays, conflicts,...), ...
AdaptabilityAttention to detailCollaborationCommunicativeCompetitivenessCritical thinkingIndependenceInterest in knowledgeKindnessOptimismProactivityProblem solvingResult OrientedService orientedTrustWillingness to compromiseCuriositySociability
Actions and modes of action of drugs in the human speciesActions and modes of action of human physiologyAdverse Events (AE)Allergy and immunologyAnalytical ChemistryBioavailabilityBiological Drug DevelopmentBiopharmaceuticalsCAPAClinical monitoringClinical pharmacologyClinical researchClinical Study DesignClinical trial designClinical trialsCommunication SkillsComplianceCRFCROCTMSDrug AccountabilityDrug DeliveryDrug metabolismDrug regulatory authoritiesDrug Safety and PharmacovigilanceeCRFEnglishGermanGood Clinical Practice (GCP)ICH guidelinesInformed Consent DocumentsInformed Consent ProcessIVRSKnowledge of the drug development processMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordNutritionOutlookPatient Screening and RecruitmentPharmaceutical salesPharmaceutical ResearchPharmaceuticalsPharmaceuticsPharmacistsPharmacodynamicsPharmacokineticsPharmacovigilancePharmacyPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)Principles and ethics of clinical researchProblem SolvingProcess improvementProtocolProteinsRecruitingRegulatory affairsRegulatory RequirementsHealthcare ReimbursementRegulatory ComplianceContinuous ImprovementStandard Operating Procedure (SOP)
Skills and Expertise
Interact with nurses Interact with physicians Monitor a clinical study Receptor Pharmacology Search literature on clinical trialsAchieve sales objectivesAdjust processes and methodsAdminister logisticsAdminister supply requestAdverse event reportingArchive documentationArchive study documentsArchive trial documentation and correspondence.Assess subject safetyAssist study siteAssist with proceduresAssist with site trainingCommunicate with investigatorCommunicate with sponsorConduct site initiationConfirm protocol complianceControl protocol versionsCreates a collaborative team environmentLead teamsPeople managementProvide trainingProvide medical insightsOral presentationWritten presentationAttend seminars, courses and meetings within and outside the companyManage Clinical Trial Management System (CTMS) Manage trial master file (TMF)Manage clinical trial files/documentsAdjust methods
Nutritherapist in Nutritherapy from CERDEN in 2015
Master of Pharmacy MPharm in Pharmaceutical Sciences from Catholic University of Louvain in 2005
Bachelor of Pharmacy (BPharm) in Pharmaceutical Sciences from Facultés universitaires 'Notre-Dame de la Paix' in 2001
Diplôme d'études secondaires in Latin-sciences-langues from Collège-Saint-Vincent, Soignies in 1999
Training and Certification
Junior CRA Certification
Local Clinical Trial Legislation (Belgium) Certification