Linh Do Email & Phone Number

Partner with functional leads to develop and manage the integrated program plan for the cholestatic liver disease program, ensuring adherence to goals, timelines and budgets.

Bethesda, Maryland

• Oversee the development and execution of post-approval CFF clinical research projects and use findings for strategic planning, including: o Phase IV clinical trials, Real World Evidence o The Data Quality Audit Program - CFF Patient Registry o CFF Biorepository

Rockville, Md

• Explored new clinical trial opportunities in CNS disorders and mental health studies.• Developed Phase 1 biomarker studies with pharmaceutical sponsor partners.• Managed study start-up efforts including site selections and program budgets.

Bethesda, Md

• Implemented protocols for Phase I-III oncology clinical trials, monitoring the clinical course of patients.• Completed study feasibility, initiation, maintained source documents and study data, managed subject recruitment, and coordinated study closeout.• Executed protocol-specific training for site staff and Principal Investigators.

Bethesda, Md

• Maintained the NIH Division of Microbiology and Infectious Diseases’ (DMID) central repository of clinical trial-related documents• Team Lead for protocol registration and clinical trial results submission to Clinicaltrials.gov• Evaluated NIH protocol and results for compliance to FDA regulations and requirements• Conducted training on protocol life cycle process and FDA compliance