Amanda Liu
Arcadia
Summary
Clinical Research Professional with 8+ years of global experience across oncology (NSCLC, mCRC, hematologic malignancies), and rare diseases, including nearly 3 years as a Clinical Research Associate. Skilled in trial oversight from start-up through close-out, with expertise in vendor and sponsor collaboration, inspection readiness, and risk-based monitoring. Experienced in reviewing study plans, managing essential documents, and supporting protocol and ICF development to ensure compliance with ICH-GCP, FDA, and international regulatory standards. Recognized for building cross-functional relationships, proactively identifying risks, and driving high-quality, timely study delivery in fast-paced, global environments.
Overview
9
9
years of professional experience
Work History
Clinical Research Associate II
Syneos Health
Hong Kong
03.2024 - 11.2024
- Oversaw global Phase II–III oncology (NSCLC) and hereditary angioedema trials, providing sponsor-level oversight of vendor activities and site performance.
- Conducted initiation, routine, and close-out visits (remote and on-site), ensuring protocol adherence, data integrity, and compliance with ICH-GCP and sponsor SOPs.
- Partnered with internal teams, vendors, and site staff to resolve enrollment challenges, implement risk mitigation strategies, and maintain inspection-ready documentation in eTMF/CTMS.
- Reviewed essential study documents for site activation and contributed feedback to monitoring plans and study procedures, ensuring operational readiness.
- Collaborated with investigators, coordinators, and vendors to streamline workflows, optimize recruitment, and enhance trial efficiency.
Clinical Research Associate I
ICON plc
Hong Kong
04.2022 - 03.2024
- Managed 9 global oncology and rare disease trials (Phase II–III) across 12 sites for Novartis, ensuring adherence to protocols, timelines, and quality standards.
- Supported sponsor oversight of CRO and vendor deliverables, including TMF quality reviews, SAE reporting, and resolution of data/safety queries.
- Conducted site initiation, monitoring, and close-out visits, while also providing guidance to coordinators on protocol amendments, compliance, and safety reporting.
- Collaborated with cross-functional study teams to address recruitment barriers, align on data quality expectations, and ensure audit readiness through periodic QC reviews.
Research Assistant
The University of Hong Kong
Hong Kong
06.2021 - 04.2022
- Led subject assessments and data collection for longitudinal studies on adolescent idiopathic scoliosis.
- Analyzed radiographs, managed clinical databases, and contributed to study publications.
Clinical Research Coordinator II - Hematology
Stanford University School of Medicine
Palo Alto, USA
09.2019 - 10.2020
- Coordinated 8 hematologic malignancy trials (Phase II–IV), managing 50+ patients on complex treatment protocols while ensuring compliance with FDA, ICH-GCP, and institutional requirements.
- Led the site launch of a high-priority COVID-19 trial, driving the site to become the highest enrolling center nationally through proactive recruitment strategies and cross-department collaboration.
- Oversaw regulatory submissions, IRB communications, and essential document packages, ensuring site activation readiness and audit compliance.
- Directed informed consent and safety reporting workflows, applying root-cause analysis to resolve deviations, and implementing CAPA plans to prevent recurrence.
- Trained and mentored new staff on protocol adherence, AE/SAE reporting, and documentation practices, providing leadership that ensured consistency and inspection readiness.
- Partnered with sponsors, CROs, and institutional leadership to address operational challenges, contributing to study-wide process improvements and protocol implementation.
Clinical Research Coordinator Associate - Hematology
Stanford University School of Medicine
Palo Alto, USA
01.2018 - 09.2019
- Served as lead coordinator for multiple hematology studies, managing patient screening, data collection, and regulatory compliance across Phase II–IV protocols.
- Coordinated with sponsors and CRO monitors during initiation, interim, and close-out visits, ensuring site audit readiness and timely resolution of findings.
- Developed tools and tracking systems to streamline patient scheduling, informed consent documentation, and data entry, reducing errors and improving efficiency.
- Contributed to institutional SOP alignment by standardizing study workflows, enhancing quality and compliance across the hematology research portfolio.
Clinical Trial Assistant
IQVIA
South San Francisco, USA
06.2016 - 12.2017
- Supported Phase II-III oncology trials with Roche/Genentech from start-up to closeout, managing trackers and maintaining TMF quality.
Medical Assistant
Renal Medical Associate
San Francisco, USA
07.2015 - 06.2016
- Assisted with patient care, monitored vital signs, and ensured efficient clinic flow in a nephrology and internal medicine practice.
Education
B.S. - Biology (Concentration in Physiology)
San Francisco State University
San Francisco, CA, USA05.2015
Skills
- Global Clinical Trial Management & Oversight (Phase II–IV) from start-up to close-out
- Vendor Management (IWRS, eCOA, central labs)
- Inspection & Audit Readiness (eTMF oversight, CAPA, compliance)
- Risk Identification & Mitigation; issue resolution and timeline management
- Training of vendors, site staff, and junior team members
- Regulatory Compliance: ICH-GCP, FDA, SOP implementation
- Oncology (NSCLC, mCRC, hematology) & Rare Disease expertise
- Multilingual (English, Cantonese, Mandarin)
Timeline
Clinical Research Associate II
Syneos Health
03.2024 - 11.2024
Clinical Research Associate I
ICON plc
04.2022 - 03.2024
Research Assistant
The University of Hong Kong
06.2021 - 04.2022
Clinical Research Coordinator II - Hematology
Stanford University School of Medicine
09.2019 - 10.2020
Clinical Research Coordinator Associate - Hematology
Stanford University School of Medicine
01.2018 - 09.2019
Clinical Trial Assistant
IQVIA
06.2016 - 12.2017
Medical Assistant
Renal Medical Associate
07.2015 - 06.2016
B.S. - Biology (Concentration in Physiology)
San Francisco State University
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