- Designed data management tools, document reconciliation tools, CRFs, ICFs, SOPs, study plans and manuals, trial master file indices, and Veeva Vault eTMF studies to anticipate and accommodate for stakeholders’ and future users’ needs- Conducted clinical risk assessment for a Phase 1 study across clinical operations, CMC, Quality, Drug Manufacture, hospital site, and safety departments to successfully mitigate 30+ risks at the beginning of the trial- Launched the company-wide SharePoint reorganization project by writing and finalizing the SOP, generating more organized folder structures, and educating colleagues on the structure and its benefits to improve company efficiency- Authored two Clinical Study Reports (CSR) by analyzing study data, requesting appropriate protocol and patient data from vendors, and generating safety and efficacy conclusions, while successfully meeting regulatory reporting deadlines- Spearheaded electronic Trial Master File (eTMF) audit across 88 global clinical sites in conjunction with the management of 8 CRAs and 1 global CRO, CAPA analysis, and risk assessment of GDPR compliance of 34 European study sites- Analyzed Chemistry, Manufacturing, and Controls (CMC) finances by creating and updating four Excel trackers across clinical trial material shipments, drug product stability testing and drug product shipments, resulting in savings of $40,000+- Led weekly clinical team, CRA, and vendor management meetings with 4+ external vendors across 3 pre-clinical and clinical studies to ensure alignment of project timelines and expectations; recorded minutes of Trial Steering Committee meetings- Streamlined and systematized CMC activities company-wide including drug product and clinical trial material shipments, investigational product (IP) destruction, and renewing USDA permits for FDA clearance of international IP shipments

Engineering Senior Capstone Design ProjectSponsored by Baxter International- Implemented, created, and tested a hands-free pharmaceutical workflow, adopted by the Sponsor, for pharmacy technicians’ use in cleanrooms and fume hoods, resulting in a 90% more sterile environment for oncology drug production in hospital settings- Conducted formative evaluations through user interviews and implemented design changes in conduct with IEC 62366 and ANSI/AAMI HE75:2009/(R)2018 Sections 7.3.4.3: Range of Motion, 7.3.4.5: Visual Work, and 18.2.4.2: Control Feedback- Generated a complete Fault Tree Analysis and subsequent Hazard Tables encompassing the end-user, hospital security, drug development, Baxter security systems, and system hardware that met 100% Acceptable Risk (Class IV) post risk-mitigation- Fulfilled the 95% accuracy rate upon conducting design verification testing for the Simulink barcode recognition software- Modeled a system diagram to subsequently purchase necessary hardware and software components under a $1000 budget- Delivered weekly communications after meetings with teammates and corporate sponsors to assess progress and timelines

- Generated 3 semi-conductor models in COMSOL and conducted and recorded trace-capacitance tests in the lab using a micromanipulator and LCR meter in regards to the Shockley-Ramo theorem- Proposed and programmed the design of an in-office FPGA temperature sensor in response to the COVID-19 pandemic

- Designed circuits for various industry types including military, aerospace, medical, and automotive- Used CAM350 to layout customer-designed PC boards, follow design rule check, and design for manufacturing- Communicated with clients on circuit specifications, generated quotes, and created invoices

TA for Engineering 101- Assisted Engineering 101 Professor, Dr. Vincent Chen, in helping students understand and practice 3D design- Analyzed student comprehension and explained design concepts in an easy-to-understand language- Hosted office hours to further help students understand design concepts and aid students in completing homework- Worked with other Teacher’s Assistants to collaborate on different methods to teach students 3D design

- Instructed kids in the local community piano and violin to be prepared for high school and college-level music programs- Scheduled weekly lessons and created individualized curricula for each student to follow- Encouraged students to practice daily and complete goals and exercises sets at lessons

Design of a 3D Anatomical Cervical Model- Designed a 3D adult-scaled anatomical model in SolidWorks for simulating cervical dilation during labor to be adopted for educational purposes by Loyola School of Nursing, in collaboration with Dr. Carol Kostovich, Associate Dean of Nursing- Utilized The Innovator’s Compass, keeping users at the center of the project, generating observations about current methodologies, defining core principles and ideating the model, to ultimately successfully fulfill the end users’ needs

- Enhanced relations with current partners and recruited new partners by placing sales calls and formulating emails- Supervised other sales interns during sales calls and monitored progress to increase client base- Increased understanding of industry standards and practices through sales and engineering

- Modeled and designed new runways for O’Hare Airport via Microstation to be constructed in 2019- Learned Microstation to design the runways to the constraints given by project managers during weekly meetings- Spoke on a panel for Women in Engineering to discuss personal experiences of being a woman in STEM- Increased understanding of industry standards and practices through engineering