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Work Background
AriBioSr. Manager, Clinical Operations/Department Lead
Mar. 2024Pangyo, South KoreaYale is currently the Global Clinical Trials Department Head (APAC) for Aribio, Co., Ltd, based in Pangyo, Gyeonggi-do, South Korea. This position is in close collaboration with partner company, Samjin Pharmaceuticals. Aribio is a globally exceling biotechnology & drug development company whose key focus is in the innovation of novel neurodegenerative disease therapeutics, primarily targeting Alzheimer's Disease and Dementia.
Her primary roles within the two companies are to lead and manage global clinical trials within the AriBio USA team, managing clinical trials planning and implementation, cross-collaborative collaboration between numerous external vendors, regulatory reporting, study data submissions, and executing response strategies throughout the clinical trial & drug approval process in the US, South Korea, and China. She is responsible for successfully seeing domestic clinical trials to completion through close cooperation with various internal & external departments. As the primary contact for domestic clinical trials, she serves as a bridge between AriBio U.S. HQ & AriBio Korea Main HQ with external CROs, clinical trial institutions/sites, clinical Investigators, domestic regulatory agencies, and more, to produce targeted clinical trial results that match optimal budgets and timelines that are consistent with global company strategies.
Samjin PharmGlobal Clinical Trials Department Head
Mar. 2024 - Apr. 2024Seoul, South KoreaHired by Samjin Pharmaceuticals, but transferred to sister company (AriBio) shortly afterwards.
Stanford University School of MedicineClinical Research Senior Program Manager (Social Science Research Professional II)
Feb. 2022 - Jul. 2023Redwood City, California, United States
Stanford University School of MedicineClinical Research Implementation and Outreach Program Director
Oct. 2020 - Dec. 2021Palo Alto, California, United StatesResponsible for designing, developing, and implementing tools, processes & strategies of a moderate to complex nature to ensure regulatory compliance, improve, and streamline regulatory processes essential to the successful management of the Department of Psychiatry’s clinical research projects. Acting as the lead resource for the Department on best research practices and GCP in the Department of Psychiatry and Behavioral Sciences – a top 10 NIH-funded Department of Psychiatry in the US. Responsible for the creation of Department-specific SOPs in line with IRB, NIMH, OHRP, and SOM guidelines for psychosocial studies in Psychiatry on, but not limited to: recruitment, clinical study protocol development, AE collection and tracking, informed consent process; study documentation, progress notes, CONSORT model; regulatory binders, etc. Close communication with investigators regarding new federal guidance on Human Subjects Research protection and expectations with regard to pest practice implementation of clinical research. Oversee and manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams and maintain metrics. Lead efforts, authorize and manage submissions to internal & external agencies. Provide final review and approval for submissions and reports. Oversee, develop and facilitate educational and compliance training programs (i.e. responsible for setting up GCP curriculum for both study staff and new investigators). Evaluate and analyze the impact on new regulations and determine how to implement within the Department. Serve as regulatory point of contact during audits. May act on behalf of Senior Management in regard to interactions with regulatory agencies. Represent department in interactions with external organizations such as industry sponsors or contract manufacturers and funding agencies, such as the NIH. Interact and advise senior management on clinical trials regulatory processes or decisions.
City of HopeSenior Clinical Regulatory Coordinator
Jul. 2018 - Oct. 2020Duarte, CASenior Research Coordinator in the Clinical Trials Office, Regulatory Track. Responsible for submission of studies through various federal (i.e. FDA) and local (i.e. City of Hope) regulatory committees, including scientific review and IRB review. The primary liaison between various IRBs who review City of Hope research, including: City of Hope IRB, Western IRB, Central IRB of the National Cancer Institute (NCI), Schulman IRB, and any other IRB that may enter into an agreement with COH. Works with investigators and sponsors to ddress oversight committee conditions and requests for necessary documentation, information, and pertinent information to ensure research study approval and success. Collect and develop criteria information for protocol submissions. Coordinates the preparation and submission of new studies, study amendments, and necessary safety reports to appropriate committees, including DSMC, C/PRMC, COH IRB, WIRB, CIRB and other necessary committees. Point person to receive all sponsor correspondence, including all pharmaceutical companies sponsoring COH research studies.
Johns Hopkins MedicineSenior Clinical Research Coordinator
Jun. 2013 - Oct. 2018Baltimore, Maryland AreaSr. Clinical Research Coordinator for Dr. Pankaj Pasricha in the School of Medicine, Department of Gastroenterology & Hepatology, Division of Digestive Diseases, at Johns Hopkins Bayview Medical Center.
Research goals are achieved through the collaboration of the Gastroparesis Clinical Research Consortium (GpCRC) at Johns Hopkins University, which is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Current NIH-funded research projects: Gastroparesis Registry 2 (GpR 2), and Aprepitant for the Relief of Nausea (APRON).
Current sponsored research projects: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week, Dose-Range-Finding Trial of 5 and 20mg Capsules of YKP10811 Administered Once Daily at Doses of 5, 10, or 30mg to Subjects with Chronic Idiopathic Constipation (SK Life Sciences, Inc.)
Currently holding the responsibilities as Senior Research Administrator and Coordinator of the newly funded a Johns Hopkins Food, Body & Mind Center at the Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center. In addition, I support gastroenterology 1st and 2nd year fellows on their clinical research projects by managing their study support accounts, budgets, contract negotiations, and patient recruitment.
Johns Hopkins HospitalResearch Intern
Oct. 2012 - Apr. 2013Baltimore, Maryland AreaResearcher at the Johns Hopkins Children's Center, Department of Child & Adolescent Psychiatry. Primary mentor: Dr Marco Grados, MD, MPH.
Primary Research Aims: parenting behaviors and behavioral disorders in children, instruments assessing the family environment and the impact on child mood and disruptive behaviors, and parent-child relationships.
Johns Hopkins Bloomberg School of Public HealthMasters Student, Children's Mental Health
Jan. 2012 - Dec. 2013
Mount Sinai St. Luke'sResearch Intern
Oct. 2011 - Sep. 2012Research Associate at the New York Obesity Nutrition Research Center at St. Luke's-Roosevelt Hospital & Columbia University College of Physicians & Surgeons at the Institute of Human Nutrition. (Mentor: Susan Carnell, Ph.D)
Studying parental feeding behaviors and child eating behavior development from infancy to adolescence. Lab work and data collection/analysis conducted at St. Luke's-Roosevelt Hospital and the New York State Psychiatric Institute in the Department of Child Psychiatry.
Publication: "Fat brains, greedy genes, and parent power: a biobehavioural risk model of child and adult obesity". International Review of Psychiatry, 2012.
Cornell UniversityResearch Assistant
Jan. 2007 - May. 2010Indoor Air Quality Hazards & Children's Health Behavior/Nutrition & Physical Activity study. In-field data collection; PC data analysis using SPSS software to study Indoor Air Quality (IAQ) samples from NY child care centers and participating homes; assist in developing effective methods for training childcare providers on issues related to reducing young children’s exposure to indoor environmental hazards; educational materials assessment & development and childcare IAQ policy research; provide public awareness of child health and air quality education through childcare training on child nutrition, physical activity, and indoor air quality; Research mentor: Dr. Lorraine Maxwell, PhD (Environmental Psychology).
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