Yuri S. Email & Phone Number

Thousand Oaks, Ca, Us

Early Development - Oncology, ObesityEU-CTR: Proficient in navigating the transition from EU-CTR to EU-CTIS, with hands-on experience in adapting to new regulatory requirements and facilitating data migration. Skilled in providing support to stakeholders and ensuring compliance with updated standards for clinical trial registration and reporting within the European Union.IVD Performance Study-Experienced in managing IVD performance study submissions across EU countries and Switzerland, ensuring compliance with regulatory requirements and facilitating smooth approval processes.

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Dublin, Ie

Early Development-Oncology-Demonstrated ability to oversee all aspects of oncology clinical trials, from protocol development to study close-out, while maintaining high standards of quality and compliance.-Skilled in fostering collaboration and communication among diverse teams of investigators, clinical research associates, data managers, and regulatory affairs professionals to achieve shared goals.-Proficient in overseeing data collection, cleaning, and analysis processes, ensuring accuracy, completeness, and integrity of clinical trial data.

Duarte, Ca, Us

-Managed Phase I-III clinical trials focusing on stage IV GI and Lung cancers, both sponsored and investigator initiated.-Successfully led the QA sponsor audit process, achieving recognition as the highest-enrollment site worldwide.-Proficient in all aspects of study startup, including serious adverse event reporting, data management, and adherence to RECIST 1.1 guidelines.

Newport Beach, Ca, Us

-Collaborated with USC Norris Comprehensive Cancer Center to manage Phase 1 clinical trials as a Research Coordinator, focusing on both investigator-initiated and sponsor-led studies for solid tumors.- At the start of my role, the clinical research program at Hoag was just beginning. I became a key member in developing and growing the program, providing clinical trial information to physicians during tumor boards, educating research nurses and clinic staff on the clinical research process, and expanding the portfolio of trials.-I managed complex Phase I trials involving fresh biopsy collections, as well as trials with intricate treatment combinations such as chemotherapy, subcutaneous injections, and intratumoral injections.

Irvine, Ca, Us

Stage IV NSCLC targeted therapy. Principal Investigator: Sai-Hong Ou MD, PhD-Demonstrated exceptional coordination skills in overseeing a Phase I/II clinical trial, resulting in the site achieving the highest enrollment globally.-Implemented efficient recruitment strategies and maintained rigorous patient engagement throughout the trial duration, leading to accelerated participant enrollment and retention.-Fostered effective communication and collaboration among the study team, ensuring seamless execution of study procedures and adherence to protocol requirements.

Los Angeles, Ca, Us

-Played an integral role in advancing longitudinal research projects sponsored by prestigious entities such as the US Department of Health and Human Services, the National Institutes of Health, and specifically, the National Institute on Aging.-Coordinated participant recruitment efforts, including screening, enrollment, and obtaining informed consent from eligible study participants.-Facilitated the coordination and execution of clinical research studies in accordance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.

•Field research data collector for the Study for the Program of Infant and Toddler care. Conducted observations, interviews and assessments of family childcare programs in California and Arizona.

Master Of Science - Ms, Clinical Research Management- Regulatory Science

Bachelor Of Arts - Ba