Shirley Vu Email & Phone Number

United States

Hayward, CA, US

Menlo Park, CA, US

• Lead CDM for REFLECTION, a multi-center, prospective, non-interventional, RWE study.
• Design, develop, test, and maintain clinical studies in GRAIL EDC, ensuring protocol-driven data collection and compliance.
• Cultivate and maintain strong relationships with site partners, including Vincere Cancer Center, Providence, Carolina Blood Cancer Care Associates, and Veterans Affairs, providing comprehensive EDC training and support.
• Spearhead data cleaning efforts, collaborating with the team to ensure data cleanliness for analysis and overall project needs.
• Program study listings, reports, and dashboards, delivering actionable insights to study teams and leadership using R.
• Develop Tableau workflows for clinical study dashboards, enhancing data visualization accessibility to study teams.

Menlo Park, CA, US

• Support start up (including eCRF design, UAT, site onboarding) of REFLECTION, a real world evidence (RWE) study hosted in the company's internally developed GRAIL EDC system
• Contribute to data cleaning processes using Medrio, ensuring high-quality data for analysis.
• Implement study dashboard metrics using R/Rmd to provide stakeholders with real-time insights.
• Provide comprehensive training to the CDM team on in-house EDC features and workflows.

US

Foster City, CA, US

• Led and supported multiple Phast III studies, serving as clinical data management point of contact for study management team throughout study timepoints, including analysis timepoints, closeout, and CRF archiving.
• Collaborated extensively with cross-functional teams, including Clinical and Statistical Programming, Clinical Operations, Biostatistics, Clinical Research, Safety, Regulatory, and Project Management, to meet.
• Drove process improvements through insightful recommendations.
• Ensured accurate translation of study protocol into Medidata Rave by designing, developing, and testing eCRFs and edit checks.

Foster City, CA, US

Austin, Texas, US

• Ensured clarity, consistency, and completeness of patient, test requisition, and ordering clinic data, and timely issue of non-invasive prenatal testing reports to clinics via laboratory information management system.
• Collaborated cross-functionally with customer support specialists, genetic counselors, statisticians, and engineers to track and resolve missing, discrepant, or erroneous data issues and queries.
• Participated in the development and implementation of data management and reporting SOPs to optimize efficiency and ensure data integrity.

San Francisco, California, US

• Assess DNA availability and preparation for next-generation sequencing and genome-wide association studies by screening through the subject sample database.
• Extract, quantify, and normalize human DNA from frozen whole blood, saliva, and buccal samples.
• Randomize and plate study samples using Biomek 3000 liquid handling robot.

• Administrative and clinical duties in the front and back office.
• Translated (Vietnamese-English) and medically scribed in EMR.
• Screened CPAP/BiPAP users and obtained compliance reports. Performed MMSE, Epworth sleepiness scale, and MOCA exams. Completed physical therapy and DME forms.
• Submitted procedure authorizations using ICD9 and CPT coding, transmitted lab referrals/medication/diagnostic imaging orders, and scheduled appointments for follow ups, sleep studies, EMG, and EEG procedures.

Fremont, California, US

• Tutor high school students in biology up to the AP level.
• Liaise between the company, parents, and students to establish the schedule and direction of tutoring to achieve common goals and guarantee success and satisfaction.

• Assessed the effect of various microbiological agents, polyphenols, phytochemicals, and oxidative stress on keratinocyte motility.
• Performed migration assays, western blots, and protein, RNA and DNA extraction. Compiled, analyzed, and created visualizations of data generated.
• Managed human keratinocyte and sebocyte cell lines, prepared lab reagents and media, and maintained a detailed and organized laboratory notebook.

• Assisted in the Cardio Thoracic Step-down Unit, Emergency Department, and Child Life department.
• Provided company and emotional support for patients and their families while maintaining an inviting, clean, and safe environment.
• Transported patients and their families upon discharge.
• Led musical recreation and art projects with patients beside and in the children's play room.
• Fed and supervised infants bedside.
• Interpreted and organized patients' EKG strips.

South San Francisco, California, US

• Wrote, reviewed, and executed risk assessments associated with the environmental control program including differential pressure, manufacturing monitoring frequency, microbial sampling, and exterior and ancillary.
• Compiled and analyzed excursion data to understand impact of construction, maintenance, and facility and utility systems shutdown/restart. Revised SOPs to enhance company program.
• Facilitated weekly multi-departmental meetings to discuss emerging issues and address trends in manufacturing environmental control.

Foster City, CA, US

• Managed transgenic mouse colonies including weaning, ear punching, tissue sampling and genotyping.
• Isolated DNA from frozen rat and mouse tissues and conducted qPcr and data analysis.
• Conducted western blots, protein isolation, and bacterial culture.
• Discussed data analysis and project direction with senior scientist and research team at weekly lab meetings.

Master Of Science (Ms), Data Science

Bachelor’S Degree, Neurobiology, Physiology & Behavior Major; Psychology Minor