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Q&A With Charina Duarte

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Charina Duarte
Manager, QA Auditor, J&J
Location: wayne, NJ United States
Joined: Sep 15th, 2024
About   (request update)
Experience
I currently work with J&J as Manager, QA Auditor
I have years of experience working in the Research & Development industry.
GROW Gig - Medical Safety Officer | Johnson & Johnson Innovative Medicine
From July 2024 to Current • 2 year(s)
 Support MSO team in assessing medical safety of Amivantamab and Lazertinib, contribute safety input to regulatory documents and provide medical safety leadership on due diligence teams.
Manager, Quality Assurance | Johnson & Johnson Innovative Medicine
From September 2022 to Current • 4 year(s)
 Independently lead planning, conduct, and reporting of QA audits across pharmaceutical, medical device, and consumer sectors while supporting regulatory inspections and real-world evidence activities.
Sr. Specialist, Quality Assurance | Johnson & Johnson Innovative Medicine
From June 2021 to September 2022 • 1 year(s)
 Planned, conducted, and reported QA routine and non-routine audits of activities, data, and processes in GxP/non-regulated environments to ensure regulatory compliance.
Clinical Research Auditor- Quality Assurance | Memorial Sloan Kettering Cancer Center
From March 2018 to June 2021 • 3 year(s)
 Conducted systematic audits for protocol compliance and GCP/ICH requirements in oncology research, served as liaison for FDA and NCI inspections.
Data Manager Consultant | Columbia University
From March 2018 to January 2021 • 3 year(s)
 Managed electronic data capture systems for Department of Ophthalmology, drove projects from concept to deployment and ensured inspection readiness.
Senior Clinical Research and Data Coordinator | Columbia University
From September 2016 to March 2018 • 2 year(s)
 Managed clinical data activities and REDCap instances for Institute for Genomic Medicine in genetics, neurology, pediatrics, and prenatal studies.
Research and Data Coordinator | Columbia University
From June 2015 to September 2016 • 1 year(s)
 Coordinated national and international sample collection, performed comprehensive electronic medical record reviews for subject screening and recruitment.
Clinical Research Coordinator | Mount Sinai School of Medicine
From June 2013 to July 2016 • 3 year(s)
 Ensured patient safety and protocol adherence in cardiology, urology, and endocrinology studies while managing data entry and adverse event tracking.
Project Coordinator | Columbia University
From February 2014 to June 2015 • 1 year(s)
 Ensured patient safety and protocol adherence following GCP guidelines, obtained detailed phenotypic data through patient interviews and medical record abstraction.
Research Coordinator | Hilda Roque Medical Office
From October 2011 to June 2012 • 1 year(s)
 Coordinated clinical research activities in private practice setting.
Medical Doctor | Fraternidad Muprespa
From February 2011 to May 2011 • 0 year(s)
 Provided occupational health medical services.
Medical Doctor | Norprevencion S.L.
From November 2008 to April 2011 • 3 year(s)
 Provided occupational health medical services.
Medical Doctor | Residencia Personas Maiores
From August 2010 to August 2010 • 0 year(s)
 Provided occupational health and geriatric medical services.
Medical Doctor | Centro de Salud Marina de Guerra
From April 2006 to April 2007 • 1 year(s)
 Provided general medicine services.
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