RITA AMBROSIO

Experience

• 

  U.O. Oncologia Medica A.O.S.G. Moscati

  Oct 2009 - Jan 2016

  Clinical Study Coordinator

  - Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.- Assists PI in communication of study requirements to all individuals involved in the study.- Conducts or participates in the informed consent process including interactions with the HRPO (IRB) and discussions with research participants, including answering any questions related to the study. - Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.- Registers participants to the appropriate coordinating center (if multi-site study).- Coordinates participant tests and procedures.- Collects data as required by the protocol. Assures timely completion of Case Report Forms.- Maintains study timelines.- Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or WU Policy on Investigational Drug/Device Accountability.- Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.- Retains all study records in accordance with sponsor requirements and University policies and procedures.- Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.- Assists PI in preparation of any modifications to the scientific protocol in accordance with Federal regulations and University and sponsoring agency policies and procedures.- Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management. Show less

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  Pharm-Olam International

  Nov 2016 - Jul 2024

  • Clinical Research Associate I

    Sept 2017 - Jul 2024

  • Clinicl Trial Associate

    Nov 2016 - Sept 2017
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  PHIDEA GROUP Srl

  Nov 2017 - Oct 2018

  Clinical Research Associate
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  Johnson & Johnson

  Oct 2018 - Jul 2024

  Site Manager
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  Johnson & Johnson Innovative Medicine

  Jul 2024 - now

  Senior Local Trial Manager