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Summary

i finished a Training as Clinical Monitor in mibeg institut, germany. i perfomed an internship as Clinical Research Associate in sam gmbh, a CRO where i was involved in a clinical research trial; my activities include initation, monitoring and close-up visit, support in Pharmacovigilance activities, subject screening protocols, completation, revision and compilation of clinical and non clinical study documents. in 2009, i received my phd in Biological Sciences. i completed my studies at the "universidad nacional del sur" in bahia blanca, argentina, performed my Training and two post doc with international scholarships. i have conducted various international research projects in the Biology field and published several interdisciplinary Publications. during my research activities my duties included: paradigm design, data collection, Data Analysis, and scientific report Editing and presentation.

 

in addition to the skills developed in my research experiences, i also strengthened my oral and written Communication and languages skills through my international work experience. i speak fluent English, spanish (mother tongue), italian and German. during my Training i have had the opportunity to work in many multicultural environments. much of this experience has been in teams. my research, as well as my Teaching activities, have been possible because of my interpersonal skills. i am reliable and organized, and very enthusiastic to pursue my Career in clinical research field.

Experiences

Current Experience

  • TMF QC Analist


    Since February 2017

    - perform qc of documents submitted to the etmf.

    - assist study teams with document scanning and uploading for etmf

    - address questions pertaining to how documents are filed in the etmf for users.

    - assist with capturing the identified tmf metrics for the etmf

    - perform ad hoc archiving tasks

    - develop and maintain strong working relationships with both internal and external collaborators and stakeholders across all geographical regions.

    - foster Communication with management throughout the organization to promote increased cooperation and accountability for results.

    - work closely with the study file management group and study teams

    - Perform QC of documents submitted to the eTMF.

    - Assist study teams with document scanning and uploading for eTMF

    - Address questions pertaining to how documents are filed in the eTMF for users.

    - Assist with capturing the identified TMF metrics for the eTMF

    - Perform ad hoc archiving tasks

    - Develop and maintain strong working relationships with both internal and external collaborators and stakeholders across all geographical regions.

    - Foster communication with management throughout the organization to promote increased cooperation and accountability for results.

    - Work closely with the study file management group and study teams

Past Experience

  • Clinical Trial Assistant (CTA)

    September 2015 --- December 2016
    - assist clinical research specialist (crs)/in-house clinical research specialist (icrs), Clinical Research Associates (cras)/in-house Clinical Research Associate (icra) and regulatory and start-up (rsu) with accurately updating and maintaining clinical systems that track site Compliance and performance within project timelines. - assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical Documentation and reports according to the scope of work and standard operating procedures. assist with periodic review of study files for completeness. - assist crs/icrs, cras/icras and rsu with preparation, handling and distribution of Clinical Trial supplies and maintenance of tracking information. - assist with the tracking and management of case report forms (crfs), queries and clinical data flow. - act as a central contact for the clinical team for designated project communications, correspondence and associated Documentation. - may accompany cras on site visits to assist with Clinical monitoring duties upon completion of required Training and with required approval. - may perform assigned administrative tasks to support team members with Clinical Trial execution.

  • Clinical Trial Assistant (CTA) Frankfurt, Germany

    December 2015 --- November 2016

  • Clinical Research Associate (CRA)

    September 2014 --- November 2014
    - monitored the assigned Clinical Trial following company sops and in accordance with gcp. - in-house monitoring of ongoing studies with the remote Data entry (rde) system ars® developed by the sam gmbh. - on-site monitoring and source data Verification including reporting and preparation of reports from monitoring visits. - acquired specific clinical and therapeutic knowledge related to studies monitored. - assisted in the administration of study materials. - assisted in the preparation of Clinical study reports. - performed trial master files of ongoing studies.

  • Clinical Monitor Training

    June 2014 --- November 2014
    - Clinical trials of drugs and Medical Devices - basic principles of Medicine and nomenclature - regulatory and legal requirements / ich-gcp - principles of pharmacology & Toxicology - medical Statistics and biometrics - Project Management - Medical writing and business English - data processing in Clinical trials

  • Instructor / Professor Teaching Assistant

    April 2003 --- February 2012
    - taught “general Biochemistry” in agricultural Engineering (department Biology, Biochemistry and Pharmacy) one course per year - provided basics knowledge in Biochemistry and Laboratory methods - created lesson plans and materials - organized and supported lectures - monitored labor activities and evaluated students - maintained and settled Laboratory materials and equipment - supported administrative tasks - researched activities. - position obtained by public competition -

  • Wetenschappelijk medewerker

    April 2009 --- April 2011
    - stuied the microbial mats that preserve sedimentary structures in current tidal flats - identifyed environmental parameters that control the development of biofilms - fellowship conicet (consejo nacional de ciencia y tecnología,argentina) -

  • Wetenschappelijk medewerker

    April 2010 --- October 2010
    - developed a method for molecular Analysis of the hainich national park groundwater - analyzed groundwater microbial diversity - elucidated the functional role of groundwater microorganisms - fellowship erasmus mundus, project eadic lot 16 -

  • Doctoral Researcher

    April 2004 --- March 2009
    - determined the magnitude of hydraulic dredging impact on benthic microflora. - evaluated the toxicity of sediment resuspension in ecotoxicological bioassays. - fellowship conicet (consejo nacional de ciencia y tecnología,argentina) -

  • Doctoral Researcher

    October 2006 --- January 2007
    - determined the ability of cultured cylindrotheca closterium and its extracellular polymeric substances to remove heavy metals ions in solution (cu and zn) - italian government fellowship. Research project –

Personality

Self Assessment :
AdaptabilitySelf-confidenceProblem solvingOrganizationInterest in knowledgeIndependenceFlexibilityEfficiencyCollaborationApproachabilityAnalytical thinkingWillingness to compromise

Knowledge

Self Assessment :
BiostatisticsClinical monitoringData AnalysisDNA sequencingFluorescence MicroscopyICH GCP guidelinesLaboratory study designMicrobiologyMicroscopyMicrosoft OfficeProblem-solving methods and troubleshootingScientific Writing
LinkedIn Assessment :
TeamworkMicrosoft OfficeLeadershipCommunication SkillsProject ManagementStatistical ToolsGraphics SoftwareResearchClinical trialsBiochemistryClinical researchmolecular biologyscienceLaboratoryICH-GCPBiotechnologyLife SciencesStatistics

Skills and Expertise

Self Assessment :
Analyze data Build and manage the Trial Master File (TMF) Control data Guide students Interpret data Monitor a clinical study Search literature on clinical trials Technology research Report data Write papersAdjust processes and methodsAttend investigator meetingAttend seminarsClinical data collectionComplete study procedureswrite and maintain clinical evaluation reportsSolve problems

Education

  • Doctor of Philosophy (Ph.D.) in Biology/Biological Sciences, General from Universidad Nacional del Sur in 2009
  • Bachelor's degree in Biology/Biological Sciences, General from Universidad Nacional del Sur in 2001

Training and Certification

  • Clinical Research / Clinical Monitoring in 2014 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    Spanish
    Native
    Italian
    Full Proficiency
    English
    Full Proficiency
    German
    Professional Proficiency

Work Preferences

  • Notice Period:
    3 weeks
  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl freelancer
    BrightOwl employee
  • International:
    Yes

Area / Region

Vaals, Netherlands

Others

Driving License
  • Yes

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