Kelly Nguyen
Caledonia,MI
Summary
Clinical Research Specialist with extensive experience in clinical trial protocols, patient recruitment, and data analysis. Demonstrates strong knowledge of FDA regulations and exceptional analytical skills. Successfully managed multiple projects simultaneously, enhancing research operations efficiency and contributing to the success of clinical trials.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Clinical Research Specialist II
Corewell Health - Pediatric Genetics
03.2024 - Current
- Supported multiple FDA submissions for investigational drug studies.
- Developed study protocols and standard operating procedures for research activities.
- Trained staff on data collection methods and clinical trial protocols effectively.
- Reviewed adverse event reports submitted by sites during trials and reported findings back to sponsors or PIs.
- Developed and maintained research protocols, case report forms, and informed consent documents.
- Maintained communication with sponsors regarding study status updates and changes in protocol requirements.
Clinical Research Specialist I
Corewell Health - Pediatric Nephrology & Genetics
Grand Rapids, MI
12.2021 - 03.2024
- Ensured compliance with federal, state, and local laws, clinical practice standards, and institutional policies.
- Developed educational materials to improve participant comprehension of study requirements.
- Trained new staff on clinical trial protocols and research conduct best practices.
- Coordinated stakeholder meetings to review study progress and updates.
- Assisted in data collection and analysis for pediatric research findings.
- Collaborated with multidisciplinary teams to uphold protocol compliance and ensure participant safety.
- Reviewed study documentation to maintain regulatory compliance and accuracy.
Health Care Research SAS Programmer
Arbor Research Collaborative for Health
Ann Arbor, Michigan
06.2021 - 11.2021
- Developed and maintained SAS programs for health research projects.
- Generated reports and visualizations to communicate findings effectively.
- Assisted in designing statistical analyses for clinical trials and studies.
- Participated in team meetings to discuss project progress and challenges.
Clinical Research Specialist
Corewell Health
11.2018 - 06.2021
- Contribute to patients' overall research experience, with principal investigator oversight, enroll participants, collect and document data from patient records/surveys within Oncology studies
- Data management and inventory of thousands of research specimens
- Administrative support to research teams, process and handle tissue and biospecimens, and placental tissue dissections
- Implemented a system improving inclusion and exclusion criteria of all current studies.
Clinical Research Assistant
Corewell Health
01.2021 - 04.2021
- Research on Racial Disparities in COVID-19
- Communicate technology needs to information services personnel
- Work with the scientific and statistical support team within the research department to build data and compute environments, develop standard protocols for analysis
- Data analysis and R programming language.
Customer Service Specialist
Best Buy
05.2015 - 01.2021
- Assisted customers in product selection and provided expert knowledge on electronics.
- Resolved customer inquiries, questions and concerns to consistently offer quality service and meet performance benchmarks.
- Resolved customer inquiries and complaints efficiently through multiple communication channels.
Data Science Intern
Corewell Health
03.2020 - 07.2020
- Connecting and consenting family members to be able to talk to patients in the ICU due to COVID outbreak
- Consenting patients to participate in COVID research
- Data entry of inputting data and metrics, and on floor tech support
- Engaging with floor staff to help with iPad configurations.
Quality Assurance Microbiology Lab Technician
Amway
10.2017 - 11.2018
- Aseptic handling of pathogenic organisms in biohood.
- Use of the STARLiMS inventory management module.
- Prepared media and reagents for microbial analysis and experimentation.
- Identified microbial organisms through analysis of culture characteristics and biochemical tests.
- Performing media quality checks and follow-up testing.
- Conducted microbiological tests on raw materials and finished products.
- Maintained laboratory equipment and ensured compliance with safety protocols.
Health Education / Environmental Health Intern
Kent County Health Department
12.2016 - 05.2017
- Revised LifeSkills curriculum (Creating activities, reformatting, & videos for each lesson)
- Created a health promotional video for LifeSkills (Recognized by the National Health Promotion Associates)
- Researched new evidence-based substance use prevention approaches.
Lab Assistant
Ferris State University
05.2014 - 05.2015
- Maintained inventory of lab supplies and ensured proper storage conditions.
- Operated laboratory equipment and performed routine maintenance checks.
- Performed preventive maintenance on laboratory equipment to ensure optimal performance.
- Organized lab test solutions, compounds, and reagents.
Pharmacy Technician
CVS Pharmacy
02.2011 - 09.2012
- Dispensed medications accurately to patients according to prescriptions.
- Collaborated with healthcare professionals to enhance patient care services.
- Prepared medications for dispensing by counting, pouring, labeling, and verifying doses.
- Created new customer profiles and updated demographics, allergies, and new medications in pharmacy computer systems.
- Restocked shelves with new supplies of medications as needed.
Education
Masters of Public Health - Public Health
Ferris State University
Big Rapids05-2021
Bachelor of Science - Public Health
Ferris State University
Big Rapids, MI05-2017
Skills
- Organizational and time management skills
- Communication and interpersonal skills
- Ability to work independently and as part of a team
- Detail-oriented and able to handle multiple tasks simultaneously
- Process improvement
- Data management
- Collaborative Institutional Training Initiative (CITI)
- Good Clinical Practice (GCP)
- Basic Life Support (BLS)
- Clinical trial management
- Informed consent process
- IRB submissions
- FDA submissions
- study protocol development
- regulatory documentation
Certification
- Collaborative Institutional Training Initiative (CITI)
- Biomedical Research
- Good Clinical Practice (GCP)
- Basic Life Support (BLS)
- MAYO Dangerous Goods
Projects
LifeSkills, Revised LifeSkills curriculum for an evidence-based program. Created a health promotional video where it was recognized by the National Health Promotion Associates., Kent County Health Department Racial Disparities in COVID-19, Analyzing the outcomes of COVID-19 and its influence on race/ethnicity and its associated underlying health conditions., Corewell Health
Publications
- COMPUTATIONAL APPROACH TO IDENTIFYING NEUROINFLAMMATION IN GLIOBLASTOMA MULTIFORME (GBM), Sherman W, Martin K, Rossell L, Nguyen K, Grady P, Zimmermann C, Chesla D, Mackeigan J., Neuro Oncol., 11/09/20, 10.1093/neuonc/noaa215.303, PMC7651204
- Bachmann-Bupp Syndrome: Clinical and Metabolomic Manifestations of DFMO Treatment, Elizabeth VanSickle, Julianne Michael, Marlie Vipond, Kelly Nguyen, Christine N. Isaguirre, Ryan D. Sheldon, André S. Bachmann, Caleb Bupp., International Conference on the Biological Roles on Polyamines, 2024
- UNIQUE ANSWERS TO UNIQUE PROBLEMS - BLOOD TRANSCRIPTOMICS IN NEONATAL CRITICAL ILLNESS, CP Bupp MD, EA VanSickle, K Nguyen, M Vipond, C Nadernejad, B Doctor, S Rajasekaran, JW Prokop., 2024
- Bupp CP, VanSickle EA, Michael J, Schultz CR, Nguyen K, Hoefer M, Rajasekaran S, Bachmann AS. Repurposing With Purpose: Treatment of Bachmann-Bupp Syndrome With Eflornithine and Implications for Other Polyaminopathies. Am J Med Genet C Semin Med Genet. 2025 Apr 1:e32138. doi: 10.1002/ajmg.c.32138. Epub ahead of print. PMID: 40167220; PMCID: PMC12353620.
Languages
- English
- Vietnamese (Spoken)
Timeline
Clinical Research Specialist II
Corewell Health - Pediatric Genetics
03.2024 - Current
Clinical Research Specialist I
Corewell Health - Pediatric Nephrology & Genetics
12.2021 - 03.2024
Health Care Research SAS Programmer
Arbor Research Collaborative for Health
06.2021 - 11.2021
Clinical Research Assistant
Corewell Health
01.2021 - 04.2021
Data Science Intern
Corewell Health
03.2020 - 07.2020
Clinical Research Specialist
Corewell Health
11.2018 - 06.2021
Quality Assurance Microbiology Lab Technician
Amway
10.2017 - 11.2018
Health Education / Environmental Health Intern
Kent County Health Department
12.2016 - 05.2017
Customer Service Specialist
Best Buy
05.2015 - 01.2021
Lab Assistant
Ferris State University
05.2014 - 05.2015
Pharmacy Technician
CVS Pharmacy
02.2011 - 09.2012
Masters of Public Health - Public Health
Ferris State University
Bachelor of Science - Public Health
Ferris State University