Elizabeth H. Email & Phone Number

Nashville, TN, US

Nashville, Tennessee, US

• Project management, medical writing, and regulatory consulting in the SiMD and SaMD spaces.

Nashville, Tennessee, US

• Executed research contracts for 45 clinical studies
• Worked with data management team to develop automatic edit actions to increase accuracy in research billing process

• Developed relationships with healthcare providers, advising physicians, and mentors
• Created business development plan
• Wrote content for website, LinkedIn, email newsletters, and pitch decks
• Managed and maintained product and business development goals in Kanban board
• Oversaw creation of legal documentation including articles of incorporation
• Conducted user interviews and translated user interview information into user needs and product requirements

Philadelphia, Pennsylvania, US

• Wrote test reports for usability studies, conducted a root cause analysis and proposed design changes based on usability findings.
• 3D printed prototypes with ABS and PLA.
• Assembled coil boards for wearable devices.
• Drafted CAD drawings in SolidWorks according to ANSI drafting standards to update BOMs.
• Developed case report forms (CRFs) for pre-clinical studies.
• Coordinated communications between research and development team and clinical research staff.

Atlanta, Georgia, US

• Organized first Georgia Tech team to attend the Global Health Case Competition at Emory University.
• TA for Grand Challenges research exploration class.
• Completed relevant coursework in CAD, digital signal processing, medical device design and development, medical device regulatory standards, and computational biology.

Atlanta, Georgia, US

• Improved a testing procedure to track the knee joint angle by using RGB LED lights and Matlab image processing toolbox.
• Assisted in cadaver lab experiments and site visits to Children's Hospital of Atlanta to collect joint sound data.

Leesburg, Virginia, US

• Updated data management plans and standard operating procedures (SOPs) for clinical affairs department.
• Designed user acceptance testing for electronic data capture (EDC) software.
• Worked in cross-functional team including clinical affairs and executive department to establish surgeon data handling strategy.
• Learned 2 programming languages, VBA and SQL, to create a clinical data management software system to manage, search, and generate reports on surgeon data.
• Wrote a software module to distribute custom database applications that eliminates $475 license fee for standard distribution package.

Leesburg, Virginia, US

• Assisted clinical data specialist with data management via MS Access and 2 electronic data capture (EDC) systems·
• Automated weekly study enrollment reports, reducing the process time by 90%.
• Wrote documentation including a data dictionary, data capture guidelines, and training guides for future software users.
• Taught reliability engineering team how to use new features in 3D radiographic imaging software for analyzing device failures.

• Tutored middle school and high school students in math subjects from pre-algebra to AP calculus.
• Developed individual learning plans for each student, creating worksheets and referring students to online learning resources.
• Helped students improve grades by up to two letter grades.

Bachelor'S Degree, Biomedical/Medical Engineering

High School Diploma