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Summary

Looking for a new opportunity as a Clinical Research Associate. Communicative and accurate person who is goal-oriented, also in a high-pressure environment. Broad background knowledge of clinical trials and therapeutic areas due to studies in Biomedical Sciences with a Master in Clinical Molecular Sciences and a traineeship Clinical Operations.

Experiences

Current Experience

  • Clinical Research Associate Trainee
    Since September 2016
    Traineeship combining on-the-job experience and trainings (theoretical, practical and skills-related) to develop the required competencies to become a Clinical Research Associate. - Cooperating with other team members, including CRA and CTS - Working in accordance with ICH-GCP guidelines, the study protocol , applicable local regulatory requirements and internal Standard Operating Procedures. - On-site monitoring activities (source data verification, source data review, drug accountability, patient recruitment discussion) under supervision of experienced CRA - Observational on-site visits (qualification, initiation, monitoring and termination visits) - Working with eCRF systems (EORTC Vista RDC, Datalabs) - Remote site contact - Following up on outstanding issues (IMPACT CTMS) - Collect and review regulatory documentation - Assist in preparation of clinical trial submission to ethic committees - Therapeutic area trainings (Oncology, Neurology) - Soft skills trainings (Outlook, OneNote, time management, French) - ICH-GCP training and assessment - Monitoring assessment based on internal SOPs

Past Experience

  • Research intern (Morphology)
    November 2015 --- June 2016
    'The angiogenic potential of leukocyte- and platelet-rich fibrin' - Cell culture - Antibody arrays - In vitro and in vivo angiogenesis assays - Cryosectioning, histological stainings - Image Processing (ImageJ) and Statistical analysis (GraphPad Prism) - Scientific writing and presentation skills (Research Proposal, Poster conference) - Critical thinking and increased independency

  • Student Worker - Cashier
    July 2009 --- June 2016
    Providing a friendly and customer-focused service

  • Database Assistant
    July 2015 --- July 2015
    Voluntary internship - Clinical data processing Completing and processing a large patient database from a clinical study on neuromonitoring at the intensive care unit.

  • Research Intern (Endocrinology)
    February 2015 --- June 2015
    'Evaluation of the luteinizing hormone receptor (LHR) in bovine luteal cells by immunofluorescence' - Immunocytochemistry - Fluorescence microscopy, Spectrofluorimetry - Image processing (ImageJ) and Statistical analysis (Systat)

  • Research Intern (Immunology)
    April 2014 --- June 2014
    'Forkhead box P3 as a possible marker for naturally occuring CD4+CD25+ T regulatory cells in Multiple Sclerosis' - PCR, Western blotting - Cell culture, Molecular cloning

Knowledge

Self Assessment :
ICH guidelinesGood Clinical Practice (GCP)AngiogenesisBiomedical SciencesClinical monitoringClinical operationsClinical researchClinical study reportsClinical Trial Management System (CTMS)Clinical trialsCRFCROCTMSDrug AccountabilityeCRFElectronic Data Capture (EDC) EnglishInformed Consent DocumentsInformed Consent ProcessIVRSLife SciencesMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordPhases of clinical development (phase I to IV)PowerPointPresentationsPrinciples and ethics of clinical researchProtocolReport WritingRoot Cause Analysis (RCA)Serious Adverse Event (SAE)Standard Operating Procedure (SOP)TeamworkTime ManagementUnderstanding of regulatory guidelinesValidation
LinkedIn Assessment :
Biomedical SciencesGood Clinical Practice (GCP)Clinical trialsTeamworkCommunicationEasily AdaptableLaboratory Skills

Skills and Expertise

Self Assessment :
Interact with nurses Interact with physicians Monitor a clinical studyAlzheimerCell cultureCommunicate with investigatorConduct maintenance visitsData verificationDistribute study documentsEnsure consistency between the protocol and CRFEnsure good clinical practice (GCP)Plan experimentsPlan work to meet objectives and deadlinesReview dataReview exclusion criteriaReview inclusion criteriaReview informed consent processSite managementUnderstand protocols

Education

  • Master's degree in Biomedical Sciences, Clinical Molecular Sciences from Hasselt University in 2016
  • Erasmus+ Exchange Programme in Biotechnology for Medical, Pharmaceutical and Veterinarian diagnostics from Università degli Studi della Basilicata in 2015
  • Bachelor's degree in Biomedical Sciences, General from Hasselt University in 2014

Training and Certification

  • ICH-GCP training certificate Certification
  • Laboratory Animal Course (FELASA B) Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
French
Professional Proficiency
Italian
Elementary Proficiency
English
Full Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Research Associate (CRA)
  • Work From Home:
    No
  • International:
    Yes

Area / Region

Leuven, Belgium

Others

Driving License
  • Yes