Edson Santos, MBA, OHE

Experience

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  UNIFESP

  Jan 2013 - Jan 2015

  Enfermeiro Residente em Oncologia
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  Santa Helena Assistência Médica

  Mar 2015 - Jan 2017

  Oncology Nurse Practitioner

  Responsabilites: Coordination of the nursing team, development of institutional protocols, financial planning and quality indicators.Achievements:• Implementation and coordination of the Chemotherapy Infusion Center, with a 50% decrease in health care expenses with the end of work outsourcing.• Development of care protocols and chemotherapy infusions, resulting in ONA III certification.

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  Hospital São Camilo SP

  Jan 2017 - Jul 2017

  Oncology Nurse Practitioner

  Working in an inpatient unit, indicator management, continuing education, member of the patient safety goal 1 group.

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  Instituto do Câncer do Estado de São Paulo - ICESP

  Aug 2017 - Feb 2020

  Clinical Research Coordinator

  Conducting randomized clinical protocols, activity planning, deviation reports and serious adverse events representation at international events for the implementation of protocols.

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  Universidade de São Paulo

  May 2018 - now

  Member of the Bioethics and Administration Group: teaching and health care

  Member of the Bioethics and Administration Group: teaching and health care. Scientific production.

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  Hospital Santa Cruz

  Feb 2020 - Oct 2020

  Senior Clinical Research Coordinator

  Responsabilites: Project management and clinical research teams, standard operating procedures, preparation of protocol change packages, Investigator's Brochure, Informed Consent Form and other pertinent documents, sending documents and guidelines to researchers for the correct submission according to deadlines.Achievements:• Implementation of Electronic Health Record to increase data quality and security.• Development of standard operating procedures (SOP) resulting in a reduction in deviations from protocols.• Capitation of new study protocols and improvements in recruitment processes, with increased visibility of the research center to sponsors. Show less

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  PRA Health Sciences

  Oct 2020 - Aug 2021

  Clinical Research Associate

  As a Clinical Research Associate, I specialized in clinical monitoring for challenging Phase II and III Oncology trials, focusing on renal, hepatic, lung, and infectious diseases. I ensured rigorous compliance with protocols, regulatory guidelines, and ICH-GCP standards. My role involved site qualification, initiation, monitoring, and close-out visits, both on-site and remotely. I maintained excellent communication with site staff to ensure data accuracy and protocol adherence. My achievements include successfully managing complex trials and overcoming challenges in diverse oncology and infectious disease studies. Show less

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  AstraZeneca

  Aug 2021 - Feb 2022

  Clinical Research Associate

  As a Senior Clinical Research Associate at AstraZeneca, I excelled in performing site qualification, initiation, interim monitoring, site management, and close-out visits, both on-site and remotely, ensuring compliance with regulatory, ICH-GCP, and protocol standards. Leveraging my judgment and experience, I evaluated site and staff performance, providing actionable recommendations and promptly escalating serious issues to the project team with developed action plans. I maintained a thorough knowledge of ICH/GCP guidelines, relevant regulations, and company SOPs/processes. Additionally, I served as a mentor for other CRAs, delivering specific training and coaching to enhance team capabilities.Achievements: Acting as a mentor for other CRAs, performing specific trainings and coaching.Participation in internal and external audit processes (Sponsor and CRO). Show less

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  ReSolution Latin America

  Feb 2022 - now

  As a seasoned Clinical Operations Project Manager in Oncology and Rare Diseases, I offer extensive experience in overseeing and optimizing clinical trial operations. I have a proven track record in successfully managing multiple high-stakes projects, ensuring they meet timelines, budgets, and quality standards. My expertise includes leading and participating in audits and regulatory inspections, where my meticulous attention to detail and thorough understanding of compliance requirements have consistently resulted in positive outcomes. My strong leadership skills and ability to implement effective improvement strategies have driven operational excellence and enhanced team performance. Committed to advancing medical research, I am dedicated to delivering high-quality clinical trials that adhere to the highest regulatory standards. Show less As a Lead Clinical Research Associate in Oncology and Rare Diseases, I oversaw all phases of clinical trials, ensuring compliance with regulatory guidelines and GCP standards. My responsibilities included site selection, feasibility assessments, and study initiation. I conducted regular site visits to monitor study progress, verify data accuracy, and provide guidance to site staff. I managed data collection and ensured accuracy and adherence to protocols. Additionally, I mentored and supported a team of Clinical Research Associates, fostering their professional growth. With a strong focus on quality assurance and continuous improvement, I collaborated with external vendors and communicated effectively with stakeholders to drive successful clinical trials. Show less

  • Clinical Operations Project Manager in Oncology and Rare Diseases

    Jan 2024 - now

  • Lead Clinical Reseach Associate in Oncology and Rare Diseases

    Jul 2022 - Dec 2023

  • Clinical Research Associate

    Feb 2022 - Jul 2022