Phuong Gardner
Berwyn,PA
Summary
Dedicated & detail-oriented Sr. Clinical Trial Assistant with 7+ years of experience in facilitating clinical trials by providing administrative support and ensuring regulatory compliance. Expert in managing documentation, maintaining databases, and liaising with diverse stakeholders.
Overview
7
7
years of professional experience
Work History
Sr. Clinical Trial Assistant
Nyxoah
Berwyn, PA
10.2021 - 07.2022
- Assisted in protocol development for Obstructive Sleep Apnea implantable device
- Collected, disseminated, and assisted in preparation of documents for ethics committee submission
- Acted as an in-house CRA with weekly meeting with sites to address enrollment & other study metrics
- Created and distributed study start-up material to sites
- Managed and revamped existing TMF in anticipation of upcoming audits; assisted in process of selecting new TMF vendor
- Streamlined clinical trial document tracking process
- Created and maintained training matrix with appropriate follow-up
- Assisted in development of a comprehensive training program for new hires; served as an onboarding mentor for new hires.
Sr. Clinical Trial Assistant
ICON
Berwyn, PA
10.2019 - 10.2021
- Supported operational aspects of all GCO managed trials, with variation across all phases of a trial (planning, start-up, execution, data analysis, reporting and closure)
- Support tracking of trial progress towards planned milestones, as well as related progress analysis and follow-up
- Ensured timely, consistent and quality set-up and maintenance of TMF requirements and processes
- Performed trial specific system set-up and access management, system data entry and responsible for internal and external meeting planning, coordination, outcome documentation, and related follow-up
- Tracked and prepared study-specific information utilizing databases, spreadsheets, and other tools; including enrollment reporting and protocol deviations
- Assisted in onboarding of new hires
Project Specialist II
Syneos Health
Blue Bell, PA
01.2017 - 11.2018
- Tracked and analyzed project details and maintained internal systems for assigned projects within CNS
- Assured compliance with local regulations, Code of Federal Regulations/International Conference of Harmonization (ICH), Good Clinical Practices (GCP) guidelines, and Company and Sponsor Standard Operating Procedures (SOPs)
- Created agenda/minutes for internal and sponsor meetings
- Coordinated all aspects of in-person meetings including team building events, lodging, & meals
- Allocated to as many as 5 trials at any given time.
Clinical Trials Coordinator
Duke Clinical Research Institute
Durham, NC
11.2015 - 01.2017
- Was responsible for coordination and implementation of research and administrative strategies associated with the management of clinical trials and research projects conducted by investigators at Duke Health and associated partners
- Focused on the use of electronic health records (EHR) for research purposes
- Supported and implemented project start up and tracked deliverables in projects that assessed healthcare systems and quality improvement
Education
MBA - Healthcare Administration
Eastern University
Wayne, PA12.2014
Bachelor of Science - Marketing
West Chester University of Pennsylvania
West Chester, PA05.2009
Skills
- Clinical Trial Management System (CTMS), Trial Master File (TMF), RAVE EDC
- Site payments / budget reconciliation
- Monthly newsletters
- Vendor management
- GCP, ICH, and company-specific SOP adherence
- Protocol Development & Protocol Amendments
- Patient recruitment, Informed consent, including creating & disseminating patient/site material
Timeline
Sr. Clinical Trial Assistant
Nyxoah
10.2021 - 07.2022
Sr. Clinical Trial Assistant
ICON
10.2019 - 10.2021
Project Specialist II
Syneos Health
01.2017 - 11.2018
Clinical Trials Coordinator
Duke Clinical Research Institute
11.2015 - 01.2017
MBA - Healthcare Administration
Eastern University
Bachelor of Science - Marketing
West Chester University of Pennsylvania
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