Yuka Bernard

Led global regional clinical leads to ensure clinical delivery of Pediatric Gastroenterology and Adult Immunology and Hematology studies in compliance with protocol, SOP and ICH-GCP. Strategized as a critical thought leader for recruitment solutions to internal and external stakeholders.

Provided global leadership to regional clinical leads, ensuring clinical delivery of Pediatric and Adult Gastroenterology and Immunology studies in compliance with protocol, SOP, and ICH-GCP. Collaborated with functional leads to achieve milestones such as Final Patient In and Database Locks.

Responsible for the delivery of all aspects of clinical studies, overseeing Clinical Research Associates (CRAs) and Site Management Associates (SMAs). Ensured consistency with ICH/GCP, ICON Standard Operating Procedures (SOPs), and applicable regulations.

Led North American CRAs/SMAs and provided support to global team members, ensuring quality standards of study deliverables and site materials. Authored and edited the Site Management Monitoring Plan (SMMP) and other study documents.

Performed remote and on-site visits to ensure site compliance to protocol, adequate enrollment, and understanding of study requirements for Long-Term Extension studies. Supported Clinical Leads and CRAs/SMAs by providing resources and training.

Led the North American CRAs/SMAs and provided support to global team members, ensuring quality standards of study deliverables and site materials. Developed the Site Management Monitoring Plan (SMMP) as author and editor.

Managed clinical and regulatory aspects of assigned studies to ensure completion on time, within budget, and in compliance with SOPs, FDA, and ICH/GCP guidelines. Planned, implemented, and managed start-up, execution, and close-out activities.

Taught and practiced wellness modalities such as nutrition, exercises, herbs, supplements, homeopathy, and hydrotherapy for a health-conscious clientele. Created Mind-Body-Spirit based programs for preventative health, including yoga and meditation.

Conducted monitoring activities for a clinical research study involving Gastroenterology and Radiology Departments for Acute Pancreatitis. Participated in site selection, reviewed clinical trial agreements, and trained investigators on study procedures and Electronic Data Capture (EDC).

Coordinated and performed in-house monitoring activities for Phase III clinical studies, ensuring compliance with FDA regulations, GCP guidelines, and Company SOPs. Tracked regulatory documentation in CIMS and Central Files for Oncology, Rheumatology, and Endocrinology trials.

Project coordinator for two clinical research trials, obtaining IRB and HIC approvals and re-approvals. Managed manuscript matrix, including editing and formatting peer-reviewed medical journals, and updated status on all manuscripts.

Activities and societies: Student Vice-President of Phi Beta Delta International Honor Society 1996, Model United Nations representing Cambodia 1994

Studied International Business with a minor in Biological Sciences, developing a strong foundation in global commerce and scientific principles. Engaged in academic and extracurricular activities, including Model United Nations.

Completed a rigorous program focused on naturopathic medicine, preparing for a career in holistic health. Gained expertise in various natural healing modalities and patient care.