Clinical Research Assistant
Resume:
Raquel Malaguthi de Souza
*********@*****.***
Pharmacist, fluent in English. Experience in regulatory affairs for clinical research. Teamwork skills. Good writing and communication. Proficient in creating documents, spreadsheet, data analysis, reports and slideshows.
Experience
• Regulatory and clinical research assistant at FIOCRUZ (Oswaldo Cruz Foundation) From Jul 2019 – Present (2 years)
Rio de Janeiro, Rio de Janeiro, Brazil
Job description: Clinical Protocol and ICF translation to Portuguese or review of the material previously translated. Adaptation of the ICF to the site standards keeping the requirements of the international sponsor. Prepare the initial submission, amendment, safety report, deviation report, SAEs report or any other communication of clinical studies to the local Institutional Review Board (IRB). Periodic review and update of the general SOPs (standard operating procedures) of the CRS (clinical research site). drugs or devices importation dossier preparation and submission. Assist in the process of signture of Material Transfer Agreements (MTA) between international institutions and FIOCRUZ according to the rules for the preservation of Brazilian genetic material. Assist in the assembly, signature collection and management of the study delegation of duties.
• Pharmacist at Community Pharmacies
From Jul 2017 - Jul 2019 (2 years and 1 month)
Rio de Janeiro, Rio de Janeiro, Brazil
Job description: Psychotropic inventory and thermolabile drugs management. Responsible for keeping updated the sanitary documentation of the store and sending montly report for local surveillance. Temperature and humidity control. Employees training. Clarification of patients' doubts, prescriptions conference and pharmacotherapeutic follow-up. Measurement of blood pressure, glucose and cholesterol. Intramuscular injection application and piercing of the earlobe.
• Customer service and medical information analyst at Pierre Fabre Group From Apr 2014 - May 2015 (1 year and 2 months)
Rio de Janeiro, Rio de Janeiro, Brazil
Job description: Customer service via email / phone handling complaints and suggestions. Elaboration of monthly trend reports with reasons for calls. Sales force support. Preparation and review of SOPs, CAPA forms and manuals. Translation of technical documents. Elaboration of presentation material about the company's products. Pharmacovigilance support. Sending medical information. Representation of the company in the working group FARMASAC (customer service working group) of Sindusfarma (National pharmaceutical industry sindicate.
• Regulatory Affairs Trainee at Flex Lab Comércio de Materiais Cirurgicos e Hospitalares From Sep 2011 - Jul 2012 (11 months)
Rio de Janeiro, Rio de Janeiro, Brazil
Job description: Develop, translate and revise technical documentation for assembling a dossier for submission to the National Sanitary Authority (ANVISA) to obtain, correct or renew the sanitary registration for health products. TO follow the publications made by ANVISA to answer requirements or update the company on renewals or new registrations granted. Preparation of products instructions for use.
• RHAE (Human Resources for Strategic Areas) Intern at Laborvida From Mar 2011 - Sep 2011 (7 months)
Rio de Janeiro, Rio de Janeiro, Brazil
Job description: Human Resources for Strategic Areas is a Grant from CNPQ (National Council for Scientific and Technological Development) that was developed in Laborvida's plant in Jacaré, Rio de Janeiro, RJ. My role was to prospect for international suppliers and products that would adapt to the Brazilian market. Another job request was writing and reviewing of documents as SOPs and internal processes. Production documents archive. Monitoring of maintenance and calibration of quality control equipment. Academic Education
• International University Center (UNINTER), Specialization in Hospital Pharmacy, 2013
• Estácio de Sá University, Bachelor of Science in Pharmacy, 2012. Complementary Training
• The National Institute of Health, Introduction to the Principles and Practice of Clinical Research (IPPCR), 2021
• The National Institute of Health, Inspection Awareness and Preparedness for CRS Inspections, 2021
• Oswaldo Cruz German Hospital, Qualification and Training in Clinical Research, 2019
• FIOCRUZ - Fundação Oswaldo Cruz, Plataforma Brasil Certification, 2019
• CITI Program, A Division of BRANY, Good Clinical Pratice, Issued Aug 2019 - Expires Aug 2021
• CITI Program, A Division of BRANY, Human Subject Protection, Issued Aug 2019 - Expires Aug 2021
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