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Vaishali I. Parekh

www.linkedin.com/in/VaishaliParekhMD • Cell: 240-***-**** • Email: adydiy@r.postjobfree.com PROFILE: A highly motivated, skilled, result-oriented professional with the ability to work with multiple disciplines in a clinical or biomedical environment. Seeking an opportunity in the field of Clinical Research. Education and Major Certifications:

• Bachelor of Arts in Biology and Psychology, 2000, Rosemont College, PA

• Genomic data science certificate in Python and Galaxy, April 2020, Johns Hopkins University

• SAS certified Associate: Programming Fundamentals December 2019

• Data Management for Clinical Research Certificate, May 2018, Vanderbilt University, TN

• Clinical Research Curriculum Certificate, March 2017, National Institutes of Health, MD Additional Certifications:

• Practical Scientific Statistics; Introductory Coding Skills; Graduate Course in Bioinformatics and Data Science, FAES, NIH Nov 2020 – July 2021

• Clinical Research Curriculum Certificate, March 2017, National Institutes of Health, MD o Institution Review Board (IRB) Volunteer January - February 2017 o Clinical Research and Protocol Navigation Training, January 2017 o Ethical and Regulatory Aspects of Clinical Research (CRCC), September – November 2016 o Introduction to the Principles and Practice of Clinical Research (CRCC), Oct 2011 to Mar 2012 o The Science of Small Clinical Trials, February -- March 2010

• Web-based training in Protecting Human Research Participants, 2017 o HRPP training, CITI course, GCP for PIs, May 2016 - January 2017 Honors and Awards:

• Selected for the 2022 NIDDK Mentoring Program.

• Selected as Clinical Research Professional advancement trainee supported by the NIH Office of Research Support and Compliance, 2019-2020 NIDDK Mentoring program.

• Recipient of the Distinguished Achievement Award from Kelly Government Solution –2021, 2020, 2019, 2018, 2017, 2016, 2015

• Mentored HiSTEP students, Summer Interns, and Presidential Class visits (2007-2017) TRAINING:

Clinical Research Professional Advancement Trainee: 2019-2021 Supported by the NIH Office of Research Support and Compliance, NIDDK Mentoring program.

• Exposure to consent forms, generating CRF, and sitting in on close-out meetings.

• Exposure to working with monitors and auditors.

• On the job with Biostatistician:

o Exposure to different types of analysis: generating summary statistics, creating analytical files and reporting results.

• Knowledge of IRB regulations, FDA Guidance, Good Clinical Practices, and CDISC SDTM and ADaM models and generating raw datasets as per standards.

• Knowledge of different clinical trial domains like Demographic, Adverse Events AE, Serious Adverse Events SAE, Vital Signs VS, etc.

CLINICAL SKILLS: Good Laboratory Procedure and Good Clinical Practice setup compatible; laboratory protocol development and management; purchasing with GPC capability, data collection, management and analysis; experience in literature search, scientific technical writing with manuscript preparation and writing, multiple first author publications; Strong practical understanding of molecular biology techniques; maintaining extensive mouse spreadsheets; proficient in Microsoft Office (Word, Excel, PowerPoint) PRISM and Excel for statistical analyses, Analyzed Page 2

data using SAS statistical Procedures such as Proc Means, Proc Tabulate, Proc Freq, Proc Summary; Knowledge of Research Electronic Data Capture (REDCap), experience designing Case Report Forms (CRF), knowledge of Biomedical Translational Research Information System (BTRIS)-NIH; knowledge of FDA Guidance, GCP and ICH standards and CDISC SDTM and ADaM models; Knowledge of working in different clinical trial domains like Demographic, Adverse Events AE, Serious Adverse Events SAE, Vital Signs VS, etc. WORK EXPERIENCE:

1. Patent Examiner, United States Patent and Trademark Office (USPTO), Alexandria, VA; Jun 2022 to Jun 2023 Summary: Examining patents involving Molecular Biology. Examiner responsibilities: managing an invention application docket, judging applications for novel inventions, interacting with shareholders, and working in compliance with patent law and regulation. 2. Research Biologist II, NIDDK, National Institutes of Health (NIH), Bethesda, MD; Apr 2009 to Jun 2022 Summary: Investigation and statistical analyses of pre-clinical models of new molecular and genetic causes of endocrine tumorigenesis in Pancreatic Endocrine Tumors (PNETs), with a focus on the mouse model, as a pre-clinical model for potential treatment

• Data Management: Using my own initiative I manage and support the data quality and management of multiple projects by analyzing, interpreting, and archiving data and protocols

• Lab Manager:

o Responsible for managing and providing technical assistance to other scientists and training junior scientists in the lab as necessary to facilitate their research

o Develop and maintain SOPs for monitoring laboratory experiments and human protocols to procure and process human tissue samples

o Oversee lab budgeting and purchasing inventory and laboratory equipment maintenance using the government purchase card

• Molecular Biologist: SME in molecular biology techniques 3. Research Biologist, Armed Forces Radiobiology Research Institute (AFRRI), Bethesda, MD; Jul 2004 to Apr 2009 Summary: Quantitative evaluation of various agents as radiation countermeasures against Hematopoietic Syndrome or other injuries caused by radiation in pre-clinical models.

• Analyzed and provided statistically relevant data, in collaboration with Cleveland Biolab.

• Performed complex molecular biology assays and used investigational tools for interrogating drug efficacy.

• Lab Duties:

o Maintained detailed records, made primary analyses, and graphed data. o Presented results in seminars, wrote parts of manuscripts, wrote portions of a paper, and amended IACUC protocols

o Had administrative duties with government purchasing authority using a GPC 4. Research Assistant, Uniformed Services University of Health Science (USUHS), Bethesda, MD; Feb 2004 to Jul 2004 Summary: Studied bacteria as a biological stimulant for improvement of antibody-based detection 5. Laboratory Research Technician, Walter Reed Army Institute of Research (WRAIR), Silver Spring, MD; May 2002 to Feb 2004

Summary: Assisted in the development of quantitative data analyses methods and data presentation for vaccines for malaria.

6. Physical Therapist Aide, Frankford Hospital & Aqua Rehab, Philadelphia, PA; Feb 2001 to Apr 2002 Summary: Assisted Physical Therapist in day-to-day interactions with patients.

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