Lin Shi
Sr. Clinical Research Associate (Dedicated Phase I Oncology, FSP for Amgen) @ ICON Strategic Solutions
About
Highly motivated Clinical Research Professional with over 7 years of Global clinical operations experience across the US, EU, and APAC regions. Demonstrated expertise in Phase I Oncology monitoring, Study Start-Up (SSU), Vendor Oversight, Site Relationship and Engagement. Skilled in regulatory compliance (FDA, ICH-GCP, EU-CTR), cross-functional leadership, and technical proficiency. Bilingual in English and Mandarin with a strong scientific background and a Ph.D. in Biomedical Engineering.
United States
Boston
Pharmaceuticals
Clinical Trial Management, Global Study Start-Up, Phase I Oncology, Project Management, Third-Party Vendor Management, Cross-functional Team Leadership, Cross-functional Collaborations, Site Engagement, KOL Engagement, Clinical Research, Good Clinical Practice (GCP), Study start up, Clinical Monitoring, Communication, Timeline Management, Problem Solving, CRO Management, Mammalian Cell Culture, Fluorescence Microscopy, Western Blotting
Experience
Site Engagement Manager (FSP for UCB)
Shanghai, China
• Work closely with both CRO and UCB Clinical Project Manager to support the clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles and using motivational tactics to ensure timely delivery of UCB trials • Engage, evaluate and develop a global network of high performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of UCB and its activities thereby increasing their desire to partner with UCB • Support assigned studies from a regional and cultural perspective & support study teams with quality related visits as needed • Assist sites with enrolment barriers by reinforcing protocol specific site recruitment plans • Work with strategic partners to ensure alignment on systems and processes for identifying and engaging sites
COVID-19 Project Manager
Pittsburgh, Pennsylvania, United States
• Work directly with Amgen Development Operations Manager (DOM) and Clinical Trial Oversight Managers (CTOMs) to track COVID-19 impacts at Country/ Site level • Manage Business Continuity Plan during COVID-19 for Amgen sponsored clinical trials, work internally with DOCS Line Managers to oversee all active sites • Oversee CRA inputs on COVID-19 site impact on a weekly basis, provide direct feedback to individual CRA Line Manager to identify and mitigate risk
Study Start-Up Specialist
Pittsburgh, Pennsylvania, United States
• Provide input into feasibility, identify clinical investigators and conducts Site Evaluation Visits (SEVs) post-feasibility to determine site suitability and selection in Amgen sponsored clinical trials • Tasked with completion of duties and responsibilities that attribute to site activation, serving as liaison for completion of study startup & site-specific documents by the site • Ensure timely site activation to meet the country goal
Clinical Research Associate
Pittsburgh, Pennsylvania, United States
• Assist Amgen in fulfilling its monitoring and site management activities and obligations in relation to clinical studies as the primary sponsor of those studies • To ensure the quality and integrity of the data collected in Amgen sponsored clinical trials

Clinical Research Associate
Irving, Texas
• Conduct pre-study, initiation, monitoring, and close-out visits according to SOPs and GCP • Responsible for overall site management for assigned sites including written and verbal communication and scheduling of monitoring visits • Responsible for completion of visit reports and maintenance of study-related databases

Research Instructor
Denton, Texas
• Provide cell culture training for Ph.D. students • Modify existing protocols, write and develop new experimental protocols • Assist principal investigator with writing grant proposal, literature review, design of experiments • Lab maintenance and management duties • Generate quote, order lab supplies and reagent, complete and update chemical inventory
Education

Chemical and Biomedical Engineering
My research focuses on exploring cell-microenvironment (cell-substrate and cell-cell) interactions by engineering physiologically relevant biomimetic platforms, therefore regulating cell behaviors and functions for understanding, diagnosis and treatment of human diseases. I have done multiple projects during my Ph.D. including: - Stiffness modulation of nanomaterials-induced fibrogenesis - Adhesion-based tumor cell capture using nanotopography (see publication) - Engineering microfluidic blood-brain barrier models (BBB) - Three-dimensional microfluidic tri-culture model of the bone marrow microenvironment (with publication)
Lin Shi's Contact Information
Phone
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