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Hire Dr. Katherine E.

United States

PhD Clinical Research Scientist | Medical & Scientific Writing, Clinical Data Analysis, Regulatory-Aligned Documentation

Profile Summary

I am a PhD candidate in Clinical Research with over 10 years of experience supporting clinical and translational research in healthcare and life sciences. My work focuses on scientific and medical writing, clinical data analysis, and regulatory-aligned documentation, particularly in hematology/oncology and clinical trials. I have extensive experience preparing and reviewing a wide range of scientific and regulatory-adjacent deliverables, including literature reviews, interim safety summaries, trial progress and data review reports, ad hoc clinical data analysis reports, and sponsor-facing data summaries used to inform study design and development decisions. I regularly work with longitudinal and registry-based datasets and contribute to analyses supporting trial feasibility, inclusion/exclusion criteria, and clinical endpoint selection. In addition to analytical work, I have authored and managed standardized documentation such as SOPs, protocols, informed consent materials, workflow guides, and end-user documentation within FDA- and ICH-GCP–aligned research environments. I am experienced in collaborative, multi-author review processes, integrating feedback from clinicians, statisticians, and investigators to produce clear, accurate, and usable written deliverables. I am available for part-time or project-based work supporting scientific and medical writing, literature synthesis, clinical data reporting, regulatory-adjacent documentation, and translational research analysis for biotech, healthcare, and life sciences teams.

Subject Matter Expertise

• ★ Data Analysis
• ★ Regulatory Writing
• ★ Technical & Scientific Writing
• ☆ Biostatistics
• ☆ Mathematical Biology
• ☆ Biochemistry
• ☆ Immunoassay
• ☆ Molecular Biology
• ☆ Epigenetics
• ☆ Basic Immunology
• ☆ Adjuvant & Antigen Research
• ☆ Data Processing
• ☆ Data Exploration
• ☆ Data Visualization
• ☆ Big Data Analytics
• ☆ Data Management
• ☆ Data Manipulation
• ☆ Text Mining & Analytics
• ☆ Data Mining
• ☆ Data Cleaning
• ☆ Data Architecture
• ☆ Statistics
• ☆ Applied Statistics
• ☆ Comparative Analysis
• ☆ Meta-Analysis
• ☆ Regression Analysis
• ☆ Multivariate Analysis
• ☆ Nonlinear Regression
• ☆ Bayesian Statistics
• ☆ Study Design
• ☆ Statistical Review
• ☆ Medical Statistics
• ☆ Health Data Analysis
• ☆ Information Retrieval
• ☆ Library & Information Science
• ☆ Abstracting & Indexing
• ☆ Digital Libraries
• ☆ Library Reference Services
• ☆ Medical Libraries
• ☆ Pharmacy
• ☆ Clinical Pharmacy
• ☆ Drug Discovery
• ☆ Drug Design
• ☆ Drug Development
• ☆ Preclinical Research
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Allergy & Clinical Immunology
• ☆ Clinical Immunology
• ☆ HLA Typing/Tissue Typing
• ☆ Medical Genetics
• ☆ Immunogenetics
• ☆ Human Biology
• ☆ Pediatric Medicine
• ☆ Oncology
• ☆ Chemotherapy
• ☆ Precision Medicine
• ☆ Pediatric Oncology
• ☆ Hematology
• ☆ Hematology-Oncology
• ☆ Leukemia & Lymphoma
• ☆ Pulmonology/Respiratory Disease
• ☆ Respiratory Therapy
• ☆ Public Health
• ☆ Epidemiology
• ☆ Health Informatics
• ☆ Healthcare Administration & Management
• ☆ Medical Practice Management
• ☆ Medical Affairs
• ☆ Healthcare Quality Improvement
• ☆ Regulatory Affairs
• ☆ Immunotherapy
• ☆ Gene Therapy
• ☆ Internal Medicine
• ☆ Medical Sciences
• ☆ Inflammation
• ☆ Cancer Research
• ☆ Cancer Biology
• ☆ Carcinogenesis
• ☆ Pediatric Hematology-Oncology
• ☆ Pharmaceutical Management
• ☆ Drug Delivery Technologies
• ☆ Liposomes
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Compliance
• ☆ Hypothesis
• ☆ Peer Review
• ☆ Research Methodology
• ☆ Meta-Research
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Gray Literature Search
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Healthcare Communications
• ☆ Research Summaries & Abstracts
• ☆ Cochrane Reviews
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Medical Copywriting
• ☆ Journal Selection
• ☆ Manuscript & Journal Article Writing
• ☆ Experimental Protocols
• ☆ Science Communication
• ☆ Literature Review
• ☆ Traditional/Narrative Literature Review
• ☆ Systematic Literature Review
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing
• ☆ Course Content Writing
• ☆ Grant Writing

Services

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Medical Writing, Technical Writing, General Proofreading & Editing

Research Meta-Research, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis, Data Visualization, Big Data Analytics, Data Mining, Data Cleaning, Data Processing, Data Insights

Work Experience

Co-Entrepreneurial Lead in Targeted Healthcare Innovation (THRIVE) Fellowship & NSF I-Corps

Icahn School of Medicine at Mount Sinai

September 2025 - Present

Clinical Research Associate and PhD Researcher

Icahn School of Medicine at Mount Sinai

June 2024 - Present

Research Systems Manager

Albert Einstein School of Medicine

December 2024 - January 2026

Quality and Data Manager for GWCC Stem Cell Transplant & Cellular Therapies Program

George Washington University Hospital

April 2019 - June 2024

Hematopoietic Stem Cell Transplant (HSCT) Donation Coordinator

Georgetown University

September 2013 - April 2019

Research Team Member and Regulatory Liaison

University of Virginia Department of Biomedical Engineering

September 2012 - November 2013

Education

Master's of Science (Biomedical Graduate Education )

Georgetown University

- Present

Doctorate (Clinical Research)

Icahn School of Medicine at Mount Sinai

- Present

Doctorate

Icahn School of Medicine at Mount Sinai

September 2022 - Present

Masters (Science)

Georgetown University

September 2016 - September 2018

Certifications

• Certification details not provided.

Publications

JOURNAL ARTICLE

Katherine Engles, Mateo Mejia Saldarriaga, Darren Pan, Caitlin Unkenholz, Tarek H. Mouhieddine, Juan Esteban Velez-Hernandez, Joshua A. Fein, Jorge Monge, Cara Rosenbaum, Roger Pearse, et al. (2024). Absolute lymphocyte count after BCMA CAR-T therapy is a predictor of response and outcomes in relapsed multiple myeloma . Blood Advances.

Nosha Farhadfar, Hemant S. Murthy, Brent R. Logan, Jennifer A. Sees, Mouhab Ayas, Minoo Battiwalla, Amer M. Beitinjaneh, Saurabh Chhabra, Miguel Angel Diaz, Katie Engles, et al. (2020). Impact of autologous blood transfusion after bone marrow harvest on unrelated donor’s health and outcome: a CIBMTR analysis . Bone Marrow Transplantation.