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Summary

experienced Clinical monitoring associate, formerly Clinical Research Associate, with about 8 years of experience in Clinical trials in Phase I, ii, iii interventional (drug or device) as well as Phase IV and observational studies, from start-up to closure, including internal/external audits.

Experiences

Current Experience

  • Clinical Monitoring Associate (CMA) II


    Since January 2015
    summary of experience: experienced Clinical monitoring associate, formerly Clinical Research Associate, with about 7 years of experience in Clinical trials and experience in Phase I, ii, iii, iv interventional (drug and device) and observational studies, from start-up to closure, including internal/external audits. therapeutic area expertise: •diabetology •oncologyOphthalmologyDermatologyCardiologyGastroenterologyHematology •pulmonology-cardiovascular •enteral Nutrition professional experience as Clinical monitoring associate ii: •conduct and facilitate specific start-up activities such as site regulatory package (srp) collection and all supporting site management activities to ensure timely site initiation. •apply expertise and independent judgment to perform all Clinical monitoring tasks and/or remote visits for designated projects in accordance with relevant regulations, sops, and study specific guidelines, ensuring Patient Safety and data integrity at all times. •act as parexel’s remote contact with assigned clinical sites and use judgment to assess and ensure overall integrity of study implementation and adherence to study science)" rel="nofollow">Protocol at clinical sites. this includes managing/supporting site activities remotely, resolving site issues, and ensuring timely/high quality Data entry at a site level •mentor project with local team members. SUMMARY OF EXPERIENCE: Experienced Clinical Monitoring Associate, formerly Clinical Research Associate, with about 7 years of experience in clinical trials and experience in phase I, II, III, IV interventional (drug and device) and observational studies, from start-up to closure, including internal/external audits. THERAPEUTIC AREA EXPERTISE: •Diabetology •Oncology •Ophthalmology •Dermatology •Cardiology •Gastroenterology •Hematology •Pulmonology-cardiovascular •Enteral Nutrition PROFESSIONAL EXPERIENCE as Clinical Monitoring Associate II: •Conduct and facilitate specific start-up activities such as Site Regulatory Package (SRP) collection and all supporting site management activities to ensure timely site initiation. •Apply expertise and independent judgment to perform all clinical monitoring tasks and/or remote visits for designated projects in accordance with relevant regulations, SOPs, and study specific guidelines, ensuring patient safety and data integrity at all times. •Act as PAREXEL’s remote contact with assigned clinical sites and use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites. This includes managing/supporting site activities remotely, resolving site issues, and ensuring timely/high quality data entry at a site level •Mentor project with local team members.

Past Experience

  • Senior Clinical Research Associate (CRA)

    November 2014 --- December 2014

  • Clinical Research Associate (CRA) II

    August 2012 --- November 2014

  • Clinical Research Associate (CRA) II

    December 2010 --- August 2012

  • Clinical Research Associate (CRA)

    December 2007 --- December 2010

  • Informant Scientific Drug

    October 2006 --- December 2007

  • Production manager - Quality control manager (RCQ) and Quality Assurance assistance

    May 2004 --- October 2006

Knowledge

LinkedIn Assessment :
Monitoraggio clinicoSperimentazioni clinicheOncologRicerca clinicaSOPCROProtocolloICH-GCPIndustria FarmacCTMSBuona pratica clinicaSviluppo clinicoCardiologCattura di dati elettroniciEmatologia

Skills and Expertise

Self Assessment :
I am an Italian mother-tongue but my English level is good either written or spoken. I acquired the ability to work in teams to work with strict deadlines and to prioritise activities. I have excellent knowledge of Windows Outlook Microsoft application Internet Browsers as well as many electronic case report forms and various companies informatics systems such as computer database system for planning managing and monitoring clinical trials Management of Electronic Documents system Document Management of the Site Regulatory Package (SRP) and Site Initiation system.

Education

  • Degree in biology; Biochemistry, molecular biology, cell biology; scientific studies from Institute University of Milan in 2004

Languages

BrightOwl Assessment:
Self Assessment:
Italian
Native
English
Professional Proficiency

Area / Region

Borgosatollo, Province of Brescia, Italy

Others

Driving License
  • Yes

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