Vi Pham Email & Phone Number

• Serve as the primary clinical project coordinator for 15+ clinical sites across the United States in a PHASE III, randomized study for treatment-resistant depression
• Lead and host 30+ meetings every month with clinical sites to ensure appropriate patient screening activity, adherence to study protocol and assessments, and positive patient interaction
• Write 30+ technical trial reports every month that details challenges, successes, and patient activity for management review
• Develop recruitment initiatives and strategies to increase screening potential at each clinical site for study enrollment
• Liase with 10+ vendors and third-party contractors, and collaborate on a day-to-day basis to facilitate study-related processes
• Review, name, and file essential documents for TMF

Fremont, CA

• Manage a self-sufficient team of 15+ individuals with a focus to build a solid foundation of collaboration, responsibility, and teamwork
• Train new employees on business operations, in addition, important professional skillsets to be better prepared for future endeavors, including public speaking, customer service, accountability, quality, efficiency.
• Familiar with proper HR related practices to ensure compliance with federal, state, and city regulations
• Oversee all operations of the business with an eye to maximize time and accuracy
• Strong customer-relationship development skills to better improve customer service and ensure that all expectations are not only met, but exceeded

Fremont, California, United States

• 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.
• Responsible for the maintenance of study databases, including entry of patients’ data in EDC for completion.
• Write, review, and oversee the implementation of investigator’s brochure (IB), study protocol, informed consent form (ICF), laboratory and pharmacy manuals, data transfer agreements (DTA), and other study forms.
• Manage biospecimen collection from clinical sites by checking shipment status to contract labs, scheduling batch analyses, and confirming proper storage conditions.
• Assess testing protocols and data analysis for drug substance/drug product manufacturing and stability testing, following ICH guidelines.
• Orchestrate meetings between CRO and Sponsor to facilitate fluid communication, present concise project updates, and produce succinct meeting minutes.

San Jose, CA

• Developed related substances method using HPLC for aNDA submission
• Wrote validation protocol for an impurity method and completed the entire protocol in a contract lab
• Serve as project manager for a high-priority project by contacting outside personnel, organizing internal and external meetings, and setting up timelines

San Jose, CA

• Proficient with HPLC and U-HPLC (Agilent and Chemstation) for analysis of small molecules
• Accurately analyze chromatographic peaks with working knowledge of HPLC conditions and parameters
• Develop methods for assays and impurity assays for molecules using GC and HPLC
• Effectively prepare cadaver skin by stripping the stratum corneum for use in skin flux experiments
• Leader of preparation and analysis of multiple-day skin flux experiments
• Troubleshoot LC and U-HPLC instruments without guidance

Mountain View, CA

• Leader of Genentech project, testing compound stability and purity
• Effectively collaborated with team on producing a novel drug-aerosol molecule
• Knowledgeable and experienced with high performance liquid chromatography (HPLC), thermogravimetric analysis (TGA), and differential scanning calorimetry (DSC)
• Determined emitted dose, particle size, and purity of aersol compounds
• Maintained a well-recorded notebook of all laboratory experiments

Davis, CA

• Improved student’s overall grades in class and on final exams
• Created personalized lesson plans to meet individual student’s needs
• Tutored in geometry, trigonometry, algebra 1&2, chemistry, biology, and SAT Prep
• Assigned and graded homework assignments for every lesson

Davis, CA

• Collaborated with fellow interns to effectively manage student-run clinic
• Actively assisted doctors with pap smears and liver screenings
• Accurately translated Vietnamese to both doctors and patients
• Measured vitals for patients in a timely manner to meet heavy flow of appointments
• Carefully followed clinic protocol when handling patient’s blood and urine samples