United States
Clinical trial professional with 3+ years of experience in site management, patient recruitment, and TMF filing plus review. Extensive experience in preparation of regulatory documents following ICH guidelines. Successfully monitor trial progress and compliance by maintaining trial master files and proper study documentation.
Oversee and manage 20+ clinical sites across the United States in a PHASE III, randomized study for treatment-resistant depression to ensure appropriate patient screening activity, adherence to study protocol and assessments, and positive patient interaction
Chief operator and manager of 15+ employees for a fast-casual restaurant with a Yelp and Google rating of 4.5+ stars and hundreds of reviews, all which signify high customer satisfaction and superb food preparation
Collaborate with CRO and corresponding contract labs to uphold study quality and data integrity of oncology Phase I clinical trial with an enrollment of 74 patients through management of patient data collection in EDC, biospecimen collection and analysis, and IP inventory and shipment.
Developed and validated related substances HPLC method for aNDA submission and serve as project manager for GMP manufacture of 1000+ transdermal formulations for animal study
Proficient with HPLC and U-HPLC (Agilent and Chemstation) for analysis and method development in drug discovery for transdermal formulations
Knowledgeable and experienced with high performance liquid chromatography (HPLC), thermogravimetric analysis (TGA), and differential scanning calorimetry (DSC)