experience in all trial related duties. currently working as home-based CRA/gtm for academic trials
Since October 2005
home-based CRA/gtm for academic trials october 2005-present
full support academic trials; all trial related duties.
(crf development -electronic and paper-, submission, feasibility, safety Training, siv, mv, site closure, reporting to ecpso, ca, …).
Home-based CRA/GTM for Academic Trials October 2005-present
Full support Academic Trials; all trial related duties.
(CRF development -electronic and paper-, submission, feasibility, safety training, SIV, MV, Site Closure, reporting to ECPSO, CA, …).
DependabilityOrganizationDiligenceKindnessWillingness to compromiseAdaptabilityCreative thinkingCuriosityApproachabilityReaction to stressImpulse commandSelf-discipline
oncologyHematologyClinical trial designMultilingualdutchFrenchEnglishProject ManagementMonitoring Study ProgressPatient Screening and Recruitment
Allergy and immunologyAnesthesiaEmergency medicineHematologyClinical trial designDesigning case report formsICH GCP guidelinesEthics submission and approval processProject ManagementPatient Screening and RecruitmentMonitoring Study ProgressClinical trial budgetingPhase IVGood Clinical Practice (GCP)Clinical trialsImmunologyRegulatory submissionsdutchEnglishPhase III
Skills and Expertise
Build and manage the Trial Master File (TMF)Act as the main line of communication between the sponsor and the investigatorAnswer, transfer and handle incoming calls as needed.Coach and provide guidance to clinical staff.Direct co-workers to achieve resultIdentify and provide training to trial team and associated staffInteract with physiciansInteract with statisticiansLiaise with doctors and other professionals throughout the studyLiaise with research team in order to accurately collect and record dataPerform administrative support duties as requiredParticipate in meetings with sponsors, monitors and regulatory authorities, as necessary.assess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.lifescienceTeach university studentsWork collaboratively with the other members of the clinical research team
Act as the main line of communication between the sponsor and the investigatorAssess subject safety during trialCoach and provide guidance to clinical staff.Ensure all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPsDistribute study supplies, including study drugswrite an understandable and appropriate subject consent form and information leafletWork with coordination and data management teamsWork with the PI to manage the day-to-day activities of the study including problem solving and protocol management.Work collaboratively with the other members of the clinical research team Supervise and/or distribute trial supplies, including the trial drug Provide general office management to keep operations running smoothly.perform regulatory authority application and approvalsBuild and manage the Trial Master File (TMF)Create clinical project documents according to the protocolDesign case record formsDetermine availability of facilities and equipment at the siteEnsure consistency between the protocol and CRFEnsure subject safety and adverse event reporting to sponsor and IRB/IEC.Initiate clinical trials Interact with physiciansInteract with computer specialistsInteract with statisticiansLiaise with doctors and other professionals throughout the studyLiaise with research team in order to accurately collect and record dataMaintain and manage internal clinical trial files and documentsmanage study budget and maintain it within financial goalsNegotiate payment schedules with sponsor companyNetwork with sponsors for potential trialsperform Data verificationPerform investigative site file reconciliation: requests any new and updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements.Plan work to meet objectives and deadlines
bachelor in nursing from Leuven in 1984
Training and Certification
Bioclinica Express 5.2 in 2017 Certification
Bioclinica Express 5.4 in 2017 Certification
DataLabs EDC in 2017 Certification
GCP-update in 2017 Certification
Medidata Rave in 2017 Certification
RDC onsite 5.0 in 2017 Certification
ICH-GCP revision 2 in 2016 Certification
GCP-update in 2015 Certification