Clinical Trials Trial

OLGA DEGA

** ********* **., ******** ****, MA ***67, Email: ***********@*****.***, Cell: 617-***-**** Summary of Experience & Expertise

● USA, 2016-pres

Senior scientist/technologist at clinical trials medical laboratory testing, ASCPc-Certified

- Performing laboratory testing for clinical trials using advanced automated analyzers, assay menu, and lab information systems in immunoassay and chemistry.

- Expertise in lab standard operating procedures (SOPs), QC/QA; Good Laboratory Practices (GLP), industry principles of process safety, and US (CLIA) regulatory requirements Latvia, 1995-2016

- MD, Clinical Pathologist, Director, Clinical Pathology Labs

- MD, Pediatrician

Technology and Skills

● Preparation of clinical trial testing operations manuals and SOPs

● Clinical Chemistry/Immunology: Siemens Atellica Solution, ABBOTT Architect 2000,ABBOTT Alinity ci Series, Roche Cobas 6000, Siemens Immulite 2000XPi

● Toxicology: Beckman Coulter AU400

● Clinical Bacteriology: Siemens Liaison XL, Vircell VirClia

● Hematology: Sysmex XN 9000 line

● Urinalysis: Roche Cobas 6500 un Cobas u611

● Coagulation: Sysmex CA-1500

● ELISA: Tecan Sunrise, ORGENTEC Diagnostika Alegria,

● Immunohematology: Bio-Rad DiaCell system

● Lab IS/IT: Orchard Harvest, Labarchive, Microsoft Team, SmartLIS, PRISCA, LabTrak, DrugTestNetwork, Microsoft Office, TeamViewer, Tecan Magillan Professional Experience

Senior Laboratory Technologist, Biomarker Research & Clinical Trials Laboratory (BRCTL), Brigham and Women’s Hospital, Boston, Massachusetts 2019-Pres BRCTL performs clinical trial testing for the Thrombolysis in Myocardial Infarction Group (TIMI), a research and clinical trial organization at Brigham and Women’s Hospital, and an affiliate of Harvard Medical School. Responsibilities include:

● Participate as a team member in the preparation of statements of work for clinical trial testing

● Implement new assay methods and applications

● Perform specimen testing in multiple clinical trials to evaluate the effects of investigational drugs on the cardiovascular system, liver, kidneys, and other organs by measuring the following cardiac biomarkers: TnI HS, TnT HS, BNP, NT-pro-BNP, Galactin 3, GDF15, CRP HS, Cystatin C, APOB, LPA, LDL Cholesterol, HDL Cholesterol, NGAL, IL6, IGF, Sars CoV2, Orexin A, Orexin B, cGMP, Leptin, TIMP-1. Technology: Siemens Atellica Solution, ABBOTT Architect 2000, ABBOTT Alinity ci Series, Roche Cobas 6000, ELISA Tecan Sunrise, Ella Protein Simple.

● QA/QC of lab equipment, conduct proficiency testing

● Prepare working testing instructions and reports

● Ordered and managed reagents and other lab supplies

● Conduct equipment calibration, train laboratory personnel Olga Dega 2 of 2

Senior Medical Technologist, Lawrence Med Lab, LLC, Woburn, MA 2017-2019 Responsibilities included:

● Planned and organized all the lab testing activities

● Supervised and performed specimen testing

● Calibrated lab equipment, performed reagent validation

● Conducted QC/QA by the US regulatory standards (CLIA) and the College of American Pathologists

(CAP) requirements

● Monitored the validity of the lab reporting and data entering into the laboratory information system

● Ordered and managed reagents and other lab supplies

● Supervised and trained medical laboratory technologists SIA Centrālā Laboratorija, Riga, Latvia

Laboratory Director & Principal Clinical Trial Investigator 1995-2016 The major Latvian laboratory organization that performs a wide variety of medical tests and participates in clinical research & trial tests (https://www.laboratorija.lv/en/) Responsibilities included:

● Supervised and consulted on medical lab specimen testing in hematology, immunohematology, bacteriology, urinalysis, immunology, clinical chemistry, endocrinology, and serology

● Planned, coordinated, and consulted on the implementation of new lab techniques, procedures, and technology

● Consulted physicians and patients

● Supervised and consulted on internal and external QC procedures, and equipment calibration, trained laboratory technologists and technicians

● Supervised and consulted on the implementation of the laboratory operating procedures and protocols in compliance with European Union standards for HIV, Hepatitis B, and Hepatitis C tests Licenses and Certificates

● ASCPc Medical Technologist Certificate, #5785, 03.01.2022 - 03.31.2028

● Biomedical Research Investigators and Key Personnel Certificate issued by The Collaborative Institutional Training Initiative in conjunction with Mass General Brigham in 2021

● Attestation Statements issued by the College of American Pathologists in 2017, 2018, 2019

● Medical Laboratory Scientist Certificate issued by the Latvian Physicians’ Society

● MD, Laboratory Pathologist License issued by the Latvian Physicians’ Society

● MD, Pediatrician License issued by the Latvian Physicians’ Society Education

● MD, Graduated with Honors, Laboratory Pathologist Riga Medical School, University of Latvia, Riga, Latvia, 1996

● MS in Medical Sciences, Graduated with Honors, MD, Pediatrician Medical School, Smolensk State University, Smolensk, Russia, 1983 Languages:English, Latvian, Russian

Citizenship:U.S. Citizen

Hobbies:Biking, Downhill Skiing, Yoga

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