Thu Huyen Ha, Ms, Ccrp
About Thu Huyen Ha, Ms, Ccrp
Ms. Thu Huyen Ha is a Sr. Clinical Study Coordinator with extensive experience in clinical research and project management. She holds a Master of Science in Applied Clinical Research and has worked in various roles across multiple organizations in the healthcare sector.
Current Role at SurModics, Inc.
Ms. Thu Huyen Ha serves as a Senior Clinical Study Coordinator at SurModics, Inc. since 2021. In this role, she is responsible for overseeing clinical studies and ensuring compliance with regulatory requirements. Her position involves coordinating various aspects of clinical trials, demonstrating her strong project management skills and technical proficiency in clinical research.
Previous Experience in Clinical Research
Ms. Ha has a diverse background in clinical research, having worked in several roles prior to her current position. She was a Clinical Research Intern at the Center for Diagnostic Imaging in 2019, followed by a role as a Clinical Research Data Coordinator at The US Oncology Network from 2020 to 2021. Additionally, she served as a Clinical Research Technician 2 at IQVIA for five months in 2019. Her experience spans various aspects of clinical research, contributing to her expertise in the field.
Educational Background
Ms. Ha earned her Master of Science in Applied Clinical Research from St. Cloud State University, completing her studies from 2018 to 2020. Prior to that, she obtained a Bachelor of Science in Pharmacy from Hanoi University of Pharmacy, where she studied from 2010 to 2015. Her educational background provides a solid foundation for her career in clinical research and healthcare.
Regulatory Knowledge and Skills
Ms. Ha possesses extensive knowledge of FDA regulations, including 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 11, 21 CFR Part 312, 21 CFR Part 812, and 21 CFR Part 58. This expertise is crucial for her role in clinical research, ensuring that all studies comply with necessary regulatory standards. Her attention to detail and organizational skills further enhance her ability to navigate complex regulatory environments.
Professional Development and Previous Roles
Throughout her career, Ms. Ha has held various positions that have contributed to her professional development. She worked as a Medical Device Study Specialist at WuXi AppTec, a Medical Marketing Specialist at Laboratoire Aguettant, and a Medical Representative at AstraZeneca. These roles have equipped her with a broad understanding of the healthcare and clinical research sectors.