Kien Nguyen

Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. Current role managing up to 25 sites across 5 different protocols (infectious disease and internal medicine) with hybrid approach of on-site and remote monitoring visit. Averaged 12 days on-site per month while maintaining greater than 98% report completion on-time and 100% TMF timeliness. Experience with Sponsor audit and multiple database locks.

• Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. • Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • Build awareness of features and opportunities of study to site. • Collaborate and liaise with study team members for project execution support as appropriate.

• Lead clinical study coordinator of pharmacological and devices trials across three major hospitals in Orange County and Los Angeles County including Long Beach Memorial, Orange Coast Memorial, and Saddleback Memorial Hospital. • Successfully initiated and led the first cardiovascular pharmacology trial at Saddleback Memorial Hospital and the first non-oncology vascular surgical device trial at Orange Coast Memorial Hospital. Initiated and led the first COVID-19 trials across multiple hospitals in Southern California. • Worked closely with sponsors, leadership, regulatory affair, and human research protection department to facilitate the internal audit plan and start-up management for multiple cardiovascular trials. Manage collaborations with several hospital departments to ensure proper trainings and strengthen partnerships with research. • Actively involved with research project budget development, billing, and strategic approaches for upcoming projects.

• Lead clinical research coordinator of numerous Phase II and Phase III studies for patients with complications of Chronic Kidney Disease (CKD), Type II Diabetes, and Anemia. Coordinated all phases of clinical trials study start up to study closure. • Familiar with regulatory affairs, FDA regulations, and Good Clinical Practice (GCP). Knowledge of research protocols, clinical research processes, including medical chart reviews, and regulations involving human subjects • Responsible for assisting in the informed consent process per SOP and FDA/IRB guidelines, screening and recruiting potential patients for adult cardiovascular clinical trials; assessed treatment patients for toxicities, dose modifications, and serious adverse events. • Conduct study procedures and assessments per protocol, including vital signs, ECG, laboratory sample collection and processing, and dosing of investigational medication as allowed by local regulations. • Complete case report forms and respond to data queries in a timely manner. Affiliated with the following centers: • NARI (Primary): 1335 W. Cypress St. Suite 204, San Dimas, CA 91773 • Azusa Dialysis Center / NARI (Secondary): 312 N. Azusa Ave. Azusa, CA 91702 • California Kidney Specialist (CKS): 1335 W. Cypress St. Suite 205, San Dimas, CA 91773 • CKS: 315 N. Third Ave. Suite 104, Covina, CA 91723

• Published Honor Thesis: Comparative Analysis of Sperm Dynamics in the Absence of a Sdic, a Recently-Evolved Chimeric Gene Cluster Exclusive to D. melanogaster • Studied function and structure of Sdic gene in Drosophila melanogaster • Analyzed spatiotemporal patterns of sperm with and without Sdic • Presented data and analyzed critical trends in genomic evolution

• Tutored for Organic Chemistry and Genetics & Evolutionary Biology • Provided instructions and encouraged critical thinking to guide students to solve homework questions • Assisted students in understanding and reviewing materials for quizzes and tests • Conducted workshops, training sessions, and presentations for fellow tutors and students