Experience

Instituto D'Or de Pesquisa e Ensino
• Brazil
• Research
• 200 - 300 Employee
• Regulatory affairs

  • May 2023 - Present


Instituto do Coração - InCor HCFMUSP

• Brazil
• Medical Practices
• 700 & Above Employee

• Clinical Research Associate - Regulatory Affairs

  • Feb 2021 - Sep 2021

  • Technical feasibility analysis of Investigator initiated studies; • Assistance and development of Clinical Trials Protocols and Informed Consent; • Elaboration and submission of the initial dossier of protocol of Investigator Initiated Studies to the Institutional Review Board (IRB) and other ethical regulatory authorities; • Experience with Plataforma Brasil and communication with the Ethics Committee (initial submissions, response to pending issues, serious adverse events, protocol deviations, partial and final reports, protocol / ICF amendments, among others); • Communication with CROs, AROs and national and international sites; • Management of sites (multicenter trials); • Data monitoring; • Development of electronic eCRF through the REDCap platform; • Planning and conducting meetings; • Maintenance of Clinical Trial files; • Document translations; • Team training; • Elaboration and validation of Standard Operating Procedure (SOPs); • Experience with Good Clinical Practices. Show less



Merck Group

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Administrative Assistant - LATAM

  • Apr 2016 - Feb 2021

  Strategy & Enablement Administrative Assistant LatamDates EmployedApr 2016 – Sep 2019Employment Duration3 yrs 6 mosLocationSão Paulo, São PauloCompliance and regulatory administrative support for the Oncology sector, scientific events, monitoring of HCP Minutes or Commercial Sponsorships, Opening and Closing of all interactions of promotional activities, sponsorships and marketing and medical events;• Monitoring of system approvals;• Support to the Department of Events in related activities;• Support to Proponents and BUs in the construction of Projects / Interactions;• Analysis / Documentation filter to include the interaction in the system;• Interaction with Merck's internal areas (Medical Affairs);• New User Training;• Monitoring and reporting to global• Audit service. Show less

• Drug Safety Associate

  • Sep 2019 - Mar 2020

• Patient Support Analyst - Endocrinology and Neurology

  • Aug 2017 - Mar 2018

  -Generate Patient Dynamics reports for patient support programs (ENDOCARE / PAP) by strictly adhering to deadlines defined (active patients-drop-out reasons-drop-out-coverage-treatment time, new patients, etc.)-Provide critical performance points by program and align with the program manager above actions- Generate the indicators and reports effectiveness and productivity of the nursing team - present the critical points / tracks and align with Nursing Supervisor actions- Follow the actions defined by the program managers and challenge effectiveness of the actions vs the result of the indicators-To follow the actions defined by the nursing supervisor and challenge effectiveness of the actions vs the result of the indicators-Be a bridge of contact with nursing team and nursing supervisor - understand and solve difficulties-Establish a review system with program managers-Create a systematic review (frequency) of performance review of the programs with those responsible for the programs-Develops specific studies on productivity - resource allocation-Accompanies projects and initiatives to keep programs updated - documentation - flow procedures (regulation)-Align / periodically review the indicators - patient dynamics targets for the different programs with business area to monitor adjustment / change need Show less


Au Pair in Ireland
• Cultural Exchange Program

  • Feb 2015 - Sep 2015


Sigma-Aldrich

• Biotechnology Research
• 700 & Above Employee

• Customer Service Representative

  • Nov 2013 - Nov 2014

  Responsible for customer service and sales through bidding, preparation of proposals, Molecular Biology and Microbiology product analysis for participation in trading sessions, control of minutes, participation of electronic trading sessions, abstraction of notifications, dispatch of documentation, warehousing, release of orders, elaboration of extension requests, challenge of public announcements along with all the routines of the bidding sector Responsible for customer service and sales through bidding, preparation of proposals, Molecular Biology and Microbiology product analysis for participation in trading sessions, control of minutes, participation of electronic trading sessions, abstraction of notifications, dispatch of documentation, warehousing, release of orders, elaboration of extension requests, challenge of public announcements along with all the routines of the bidding sector



Grupo Erviegas

• Brazil
• Biotechnology Research
• 1 - 100 Employee

• Customer Service Representative

  • Nov 2012 - Nov 2013

  Sale of health products, Immunohistochemistry, Anatomical Pathology, Molecular Biology, Histopathology and Antibodies analysis, as well as Research and Analysis of edicts, preparation of proposals, sending and control of documentation, participation in electronic trading sessions Bec, Comprasnet , bank of Brazil among others . Make orders, control of delivery of material, appeals of resources, after sale and other administrative routines. Sale of health products, Immunohistochemistry, Anatomical Pathology, Molecular Biology, Histopathology and Antibodies analysis, as well as Research and Analysis of edicts, preparation of proposals, sending and control of documentation, participation in electronic trading sessions Bec, Comprasnet , bank of Brazil among others . Make orders, control of delivery of material, appeals of resources, after sale and other administrative routines.



Dasa

• United Kingdom
• Environmental Services

• Clinical Research Assistant

  • Nov 2011 - Nov 2012

  Clinical Research Assistant, reporting directly to the Research Coordinator, working in the support laboratory to receive samples from several centers in Brazil and Globals, controlling all study protocols if they were in compliance, registering exams in client systems such as Quintiles and Quest Diagnostics. Clinical Research Assistant, reporting directly to the Research Coordinator, working in the support laboratory to receive samples from several centers in Brazil and Globals, controlling all study protocols if they were in compliance, registering exams in client systems such as Quintiles and Quest Diagnostics.