Lauren Wu

Scientist Iii, R & d @Thermo Fisher Scientific

Coordinates multiple aspects of clinical studies under GCP, ICH, and OSHA compliance. Manages and tracks IUO/PEO clinical materials across investigational sites (US and international). Oversees study compliance and regulatory essential documentation and alignment of site study binders in addition to maintaining eTMF. Experienced with study monitoring and study close-out visits activities, monitoring reports, and follow up letters. Works closely with site coordinators and Site Investigators to maintain study compliance and supports IRB submission activities. Manages the on-site donor program to collect fresh samples to support assay development for multiple projects. Oversees the IRB submissions and approval as well as the continuous review process for the in-house donor program. Performs donor consent, provides protocol and GCP training to Study Staff and Investigator. Generates collection kits and distribution to donors and confirms with Study Staff that enrollment targets are met for each collection. Identifies and evaluates external sites (US and International) for R&D sustaining projects and clinical evaluations. Supports qualification of new suppliers, negotiates contracts, and reviews budgetary proposals with upper management. Project management support for external site activities including reviewing resource allocation, budget, site identification, risk mitigation, timeline implementation, inventory tracking, and execution to protect high dollar revenue. Maintains project timelines using SmartSheet. Works cross-functionally with R&D, Regulatory, Quality, Commercial, Legal, Global Trade Compliance, and external validation sites. Biospecimen Program Management to support immunoassay development (CJ & F, 510K, De Novo submission), applications, sustaining, and product release. Developed SmartSheet request form and tracker for internal customer requests.