Lily Hwang Email & Phone Number

San Francisco, CA

• Responsible for leading, directing and coordinating the development, implementation, and completion of Phase I and II clinical trials within an international clinical research consortium.
• Led multidisciplinary global study management teams and sites in the Allergy portfolio.
• Established the project goals for protocol development, trial start-up, and implementation by preparing and reviewing all trial-related documents and budgets, planning and documenting trial activities, and managing.
• Trained global sites on protocol requirements, data collection tools (eCRFs), and adverse event reporting.
• Led a cross-functional workgroup to implement new CTMS and write configuration process guidelines.

San Francisco, CA

• Responsible for developing site regulatory plans for the Cancer Center’s clinical trials, and providing guidance to study teams on regulatory requirements.
• Drafted new and modified protocol synopses and consent forms for IRB approval on Phase I – III industry-sponsored and investigator-initiated therapeutic cancer trials and IND submissions in multiple specialties (e.g..
• Tracked and documented protocol lifecycles on the center’s CTMS (OnCore), and ensured proper version control and study document distribution to study teams.

New York, NY

• Managed the daily activities of Research Coordinators to aid basic scientists and clinical/translational researchers (among 9 partnering institutions) in the conduct of research; facilitated logistical issues, such as.
• Developed standard procedures and best practices in the center’s operations, and evaluated study applications for the Advisory Committee to determine support team resource approval.
• Facilitated protocol development from concept through regulatory approval by leading Investigators to the center’s resources and research process, gave tutorials on the electronic application system, pre-reviewed.
• Initiated and led workshops for seed funding award applicants to assist with grant development and pre- and post-award administration.
• Represented the CTSC at national consortium activities, teleconferences, and meetings.
• Developed a web-based reporting software system with the Informatics Program Developer to track utilization of the center’s resources across partner institutions (available to the national consortium).

New York, NY

• Executed the gene transfer and genetic clinical research program in compliance with local and federal regulations, GCP guidelines, by working closely with senior staff, clinical research team, regulatory agencies, gene.
• Supervised Research Coordinators for proper study management including adverse event reporting, maintaining study files, reviewing regulatory submissions; and advising on regulations and guidelines.
• Assisted in preparing investigator-initiated gene transfer INDs from pre-IND through study start-up, participating in pre-IND and IND teleconferences with FDA and NIH-Recombinant DNA Advisory Committee (RAC); and.
• Prepared protocol submissions to local and federal regulatory agencies and met all internal and regulatory agency deadlines. Tracked all submissions through the approval process.
• Monitored daily study activities of Doha, Qatar clinical site to ensure the study is carried out in compliance with GCP guidelines, including maintaining daily correspondence with site, issuing queries, resolving.

New York, NY

• Recruited research subjects and assisted in routine patient care activities, including phone screenings, scheduling appointments, processing all patient arrivals and billing.
• Coordinated successful preparation for FDA inspections of two gene transfer studies, with no observation (no form FDA 483 issued).