Marina Nakamura

Experience

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  Scentryphar Clinical Research

  Aug 2009 - Mar 2011

  Assistente de Pesquisa Clínica

  Study Coordinator: documents and filing source documents, source verification at trial sites to ensure compliance with the protocol, FDA regulations, ICH-GCP guidelines and/or other guidelines to fulfill local regulations for Phase III outpatient study in pneumological area.Clinical Research analyst: technical activities such as making clinical and final reports, analytical and statistical reports review, documents audit and filing, ICH-GCP guidelines and/or other guidelines to fulfill local regulations for Bioequivalence studies. Show less

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  Pharmagenix Projetos em Medicina Farmacêutica

  Mar 2011 - Dec 2011

  Analista de Pesquisa Clínica

  Clinical trial monitoring activities such as safety reports review, documents audit and filing, source verification at trial sites to ensure compliance with the protocol, FDA regulations, ICH-GCP guidelines and/or other guidelines to fulfill local regulations for Phase III othorrinolaringology area and Phase IV outpatient study in orthopaedic area. Involved in protocol and SOP/GCP training. Also, involved with Regulatory staff (CEP and ANVISA).

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  PPD

  Jan 2012 - Jun 2014

  Project Assistant

  - Review regulatory documents for proper content in accordance with FDA, ICH/GCP, PPD and client company appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory Affairs and/or the client from Latin America;- Log outstanding issues in project related tracking tools, development of tools to support management and team;- Develop and maintain assigned data points within the CTMs database according to the established conventions and tools for the project, within specified timelines;- Oversee the execution and dissemination of study related information, including project tracking update information to clients, clinical study teams and other PPD departments for Latin America;- Co monitoring activities to ensure protocol compliance by assessing source documentation, CRF, investigational product, physical inventory, records review, essential documents submission, query corrections, IRB/EC and regulatory agencies approvals, ICF development,. Resolution of deficiencies and issues expeditiously, propose solutions and follow up on issues through to resolution;- Closely perform site management and monitoring in accordance with monitoring plan;- Manage study data including the review and tracking of study documents to ensure completeness and accuracy; Management of clinical supplies;- Facilitate effective communication between investigative sites, the Client Company and Project team; Show less

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  Eurotrials

  Jun 2014 - Jun 2015

  CRA

  - Assigned CRA for Pharmaceutical companies sponsored studies in Brazil. Performing Site management, Pre study, initiation, Interim and Close out visits according to applicable Sponsor’s SOPs, GCP/ICH guidelines and European Directives. Development of country-specific ICFs, IRB/EC/INVIMA submissions, IP and supplies importation, SAE conciliation, AE adjudication, record keeping.- Country and International trial experience includes monitoring to ensure protocol compliance by assessing source documentation, CRF, investigational product, physical inventory, records review, essential documents submission, query corrections, IRB/EC and regulatory agencies approvals, ICF development; - Resolution of deficiencies and issues expeditiously, propose solutions and follow up on issues through to resolution; - Closely perform site management and monitoring in accordance with monitoring plan. - Provide trial status trackers, site payments and progress reports;- Provide active support and tasks status to managers;- Ensure study systems are updated;- Perform QC check of reports. Identify potential investigators and trial sites;- Facilitate effective communication between investigative sites, the Client Company and Project team;- Support on study, sites and laboratory audits. Show less

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  PRA Health Sciences

  Jun 2015 - Mar 2018

  CRA II

  - Performed validation visits and site initiation visits according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.Performed monitoring duties as specified in the relevant procedures. - Performed SDV, r-SDV, Source Documento review and validate CRF entries.Generated and resolved queries as required.- Controled IP accountability through physical inventory and records review. Control trial supplies ordering, dispatch and return.- Ensured the proper and complete essential documents prior to trial start up on an ongoing basis throughout the study.- Provided training for unexperienced sites.- Attend to Investigator’s meetings and conference calls (regional/global).- Provided trial status tracking and progress reports as required by the Project Manager or Clinical Team Manager. Assisting in preparation of project tools and sharing suggestions with team members.- Documented all observations in reports and letters in a timely manner according to accepted business writing standards. - Maintain a working knowledge of GCP, Corporate global SOPs and applicable client SOPs.- Facilitated effective communication between sites and sponsor project team through written, oral and electronic contacts.- Facilitated and respond to company, client and regulatory audits.Contributed to the project team by mentoring new members.- Developed collaborative relationships with sites, client company personnel and study vendors. Show less

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  Covance

  Mar 2018 - Nov 2019

  CRA II
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  Labcorp Drug Development

  Nov 2019 - Oct 2022

  • Associate manager

    Nov 2021 - Oct 2022

  • Senior CRA

    Nov 2019 - Nov 2021
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  Labcorp Drug Development

  Feb 2023 - May 2023

  Associate Manager Clinical Operations
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  Fortrea

  Apr 2023 - now

  Associate Manager Start-up Operations