Pretty Joy

Master's

Pharmaceutical Sciences

PPD, INC

CLINICAL TRIAL COORDINATOR - CENTRAL

- PROJECTS - 1 - A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib - Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable - Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial - 2 - A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability - Pharmacokinetics and Anti-tumor Activity of HBM4003 in Subjects With Advanced Solid - Tumors - 3 - A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate - Efficacy and Safety of Lenabasum in Dermatomyositis - Reviewed regulatory documents in accordance with FDA, ICH/GCP, PPD, and client company SOP - Liaised with monitors and investigator sites to resolve outstanding regulatory issues identified through - Coordinated in eTMF (Veeva vault) / CTMS Project file setup. Managed eTMF by completely - Performed file reviews, entered metadata, and maintained log in the clinical database to ensure - Assisted in the creation of study-specific documents and plans (e.g., Communication Plan, Project Plan, Monitoring Plan, etc.), study logs (e.g., Drug Accountability Log, Site Visit Log, etc.), and study trackers - Established and distributed the study Q&A / Directives log to the project team - Created and maintained Task List for the study and continued to manage the progress of the clinical