Clinical Data Coordinator and Quality System CoordinatorAntwerp, Belgium
Since April 2016
i also follow up on issues that are detected in the system.
As a clinical data coordinator, I am responsible for creating studies in the Electronic Data Capturing system, and to create sample Case Report Forms.
I also follow up on issues that are detected in the system.
As Quality System Coordinator, I am responsible for the creation and timely review of quality documents in the company's document quality system.
Clinical Research Coordinator Antwerp, BelgiumDecember 2013 --- April 2016
as a Clinical Research Coordinator, it was my responsibility to organize the conduct of studies at the Clinical pharmacology unit: i ordered the necessary materials, wrote manuals, attended dosings, made sure staff Planning was ok,...
AdaptabilityApproachabilityAssertivenessAttention to detailCollaborationCommunicativeCoordinationCreative thinkingCritical thinkingCuriosityDependabilityEfficiencyFlexibilityIndependenceInterest in knowledgeKindnessOptimismOrganizationProactivityProblem solvingResiliencyResponsibilityResult OrientedSelf-confidenceSelf-disciplineService orientedSociabilityTrustWillingness to compromise
Phase IBudget ManagementCAPAClinical operationsClinical trial managementClinical trialsComplianceCRFCRF designData cleaningData entryData ManagementeCRFEDCEnglishGood Clinical Practice (GCP)ICH guidelinesInformed Consent ProcessLeadershipLife SciencesMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordOutlookPhase IPhases of clinical development (phase I to IV)Presentation SkillsPrinciples and ethics of clinical researchProblem SolvingProject CoordinationProject ManagementProtocolQuality AssuranceQuality Control (QC)Quality Management System (QMS)RecruitingRoot Cause Analysis (RCA)Standard Operating Procedure (SOP)Writing Study Procedures and SOPs
Skills and Expertise
Analytical skills Control data Create SOPs Design case record forms Interact with nurses Interact with physiciansAdjust processes and methodsAdministrative supportArchive study documentsassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Attend investigator meetingCapture data on source documentsClinical data collectionCommunicate with investigatorCommunicate with sponsorCommunicate effectively on different company levelsComplete case report form (CRF)Coordinate projectsCoordinationCreate SOPsDevelop ICH/GCP compliant processesEnsure consistency between the protocol and CRFFacilitate sponsor monitoring visitsInteract with nursesInteract with pharmacistsInteract with physiciansLead teamsManage data collection systemPeople managementproject managementProvide trainingReview protocolsSchedule trial visitsSet up a clinical studyTrain StaffUnderstand protocols
Bachelor in Archaeology from KU Leuven in 2009