Richie Phan Email & Phone Number

California, United States

San Francisco, California, US

HBV Program Oversight

San Francisco, California, US

HBV Program Oversight

San Francisco, California, US

• Global lead on two Phase II trials for a universal "off-the-shelf" allogeneic cell therapy in single cord blood transplants and for chemotherapy induced neutropenia in patients with acute myeloid leukemia
• Ensured studies were carried out according to the study protocol, SOPs, and ICH/GCP regulations and study specific manuals and procedures
• Wrote or contributed to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
• Assisted in the identification and hiring of appropriate CROs and third-party study vendors
• Oversaw performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to VP of.
• Monitored performance of investigational sites for clinical studies; ensured accurate and timely visit reports from all site visits

Morrisville, North Carolina, US

South San Francisco, CA, US

• Managed overall trial activities with multiple vendors and cross functional team members on three global Phase III trials in the Fostamatinib ITP program according to timelines, Rigel quality standards, and ICH/GCP
• Reviewed and quality checked protocols, electronic case report forms, monitoring plans, site visit reports, data listings, and clinical study reports
• Generated/reviewed informed consent forms and managed the review/approval process with cross functional team members
• Monitored essential document collection to ensure it met quality standards set by Rigel
• Assured site monitoring and compliance within protocol and regulatory requirements to ensure high-level quality of data
• Reviewed and manage resolution (including implementation of corrective and preventive action plans) of site and monitoring issues/deviations

• Provided support on the day to day activities of the Clinical Operations Team
• Provided support on two global phase II and III clinical trials
• Managed with multiple vendors/CROs
• Reviewed and Approved IP Release/Site Activation Packages
• Reviewed final monitoring reports
• Assisted the clinical supplies team in the global management of IP

San Francisco, California, US

• Managed 4-5 clinical trials, both industry and investigator initiated, in the Phase 1 Investigational Oncology Unit at the Helen Diller Comprehensive Cancer Center
• Ensured aspects of study initiation of protocols are developed and report study progress to appropriate agents
• Maintained data integrity for multiple electronic data collection systems including OnCore, Medidata, & Oracle RDC
• Assured compliance with the Code of Federal Regulations and the ICH guidance on Good Clinical (Research) Practice as well as UCSF Institutional policies
• Ensured patient compliance with research protocols by acting as a liaison between patients and their healthcare team

Los Angeles, CA, US

• Project manager on several non-therapeutic and therapeutic studies in the Division of Rheumatology
• Assisted PI with assurance of FDA/NIH compliance regulations and good clinical practices for study site
• Assisted PI in preparation of study application packets, including consents forms, all critical study related documents (FDA forms, radiation saftey, pharmacy, etc.) and submission to the IRB, appropriate departments.
• Assisted PI in preparing and submitting all amendments, updates, continuing reviews, adverse events, reports, and other modifications as required by regulations and the study protocols
• Assisted PI with recruitment and selection decisions regarding potential study participants and obtain clinical information
• Assisted PI with research project development

Los Angeles, CA, US

• Research assistant for Project Aware, a behavioral research study sponsored by the NIH
• Helped implement national clinical protocol at site level, by developing local standard operating procedures
• Responsible for the recruitment, consenting, and retention of study participants
• Maintained data integrity for the InForms EDC system