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Experiences

Current Experience

  • Clinical Study Coordinator / Data management


    Since July 2012
    - Clinical Data entry, case report forms (crf) and / or electronic crf (eCRF); - management and timely resolution of queries; - Document Management (Ethics committee); - drugs management (registration and Accounting, Compliance with the requirements of conservation, control and re-supply, use of iwrs/ivrs system; - reconciliation documents; - monitoring of drugs (adrs reports, collection and circularization of the sae/ susar); - management of shipments of Biological samples to centralized laboratories; - management of monitoring visits (siv,miv,cov); - interaction with a team of the Clinical study (investigators, nurses,Ethics committee, Pharmacists, sponsor); - collaboration with the departments of the Hospital (radiology, Laboratory Medicine, Pathology); - participation to national and international meeting; - Clinical data entry, Case Report Forms (CRF) and / or electronic CRF (eCRF); - Management and timely resolution of queries; - Document Management (Ethics Committee); - Drugs Management (registration and accounting, compliance with the requirements of conservation, control and re-supply, use of IWRS/IVRS system; - Reconciliation documents; - Monitoring of drugs (ADRs reports, collection and circularization of the SAE/ SUSAR); - Management of shipments of biological samples to centralized laboratories; - Management of monitoring visits (SIV,MIV,COV); - Interaction with a team of the clinical study (Investigators, Nurses,Ethics Committee, Pharmacists, Sponsor); - Collaboration with the Departments of the Hospital (Radiology, Laboratory Medicine, Pathology); - Participation to national and international meeting;

Past Experience

Personality

Self Assessment :
Attention to detailCuriosityOrganizationResponsibilityAuthenticityCoordinationCritical thinking

Knowledge

LinkedIn Assessment :
ICH-GCPClinical Data ManagementStudy CoordinationData AnalysisDatabaseSPSSRStatisticaSASLaTeXRicerca clinicaAnalisi dei dati

Skills and Expertise

Self Assessment :
Complete case report form (CRF) Report dataArchive study documentsClinical data collectionCollaborate with principal investigatorCollaborate with medical teamCollect patient forms and questionnairesCoordinate with the ethics commiteeData analysisData entryMonitoring enrolmentReport serious adverse events (SAE)Resolves queriesRespond to audit findingsScreen patientsShipment of biological specimenStatistical analysis

Education

  • Degree in Social Sciences and Health Statistics in Statistics from Università degli Studi di Palermo in 2011

Training and Certification

  • Inroduction to the Clinical Drug Development Process: ICH Good Clinical Practice for Clinical Trial Sites in 0000 Certification

Languages

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

Work Preferences

  • Positions I am interested in:
    Clinical Data Manager (DM) Clinical Research Coordinator Clinical Research Associate (CRA) Quality manager
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Palermo, Italy

Others

Driving License
  • No

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