Bright, outgoing, pro-active individual with keen interest in pursuing a career in Business. Natural leader that works well with a team and a skilled ability to build trust with others. Quick learner with a proven ability to deliver results. Experienced in professional and customer service-based environments. Pragmatic, composed, creative, and powerful when given room to expand. Exceptional ability to manage and communicate. Honest and trustworthy individual with a strong business acumen.
● Sales and POS software
● Verbal and written communication
● Knowledge of GCPs
● Public speaking
● Attention to detail
● Time management
● Protocol development
● Team player
● Basic clinical research
● Microsoft Office systems
● Veeva Vault
Exelixis, Alameda, CA - Clinical Operations Specialist/TMF Manager October 2018 - May 2019
● Managed processes and procedures for filing, retrieving, storing, preserving, and protecting of clinical records and collaborated with other departments where such procedures/processes overlap.
● Helped to establish a quality oversight process for the retrieval and processing of Clinical Records.
● Conducted facilities planning by reviewing short- and long-term resource and space requirements to identify and evaluate possible options for on and off-site locations.
● Collaborated with functional groups within the company to develop, implement and maintain a disaster preparedness and business continuity program.
● Knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation
● Ensured compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study specific procedures.
Cruise Automation, San Francisco, CA - Automated Vehicle Trainer August 2018- October 2018
● Collaborated closely between the software and hardware engineers as well as software operations specialists to advance the companies technologies and internal workflows, and ultimately help shape the product roadmap.
● Assist researchers and engineers to implement/support the development of algorithms for autonomous driving.
● Utilize proprietary software to gather data and troubleshoot in a variety of real world situations, while simultaneously providing detailed and accurate feedback to our engineers.
● Assisted engineers and team members in migrating research code to operate on test and production systems.
● Learned to troubleshoot systems in real time and how to diagnose multiple problems within the software, while under pressure or in extreme situations.
● Reviewing software code to diagnose problems the hardware may or may not encounter.
Tech & Health Organization, Oakland, CA - Intern October 2017 - December 2017
● Responsible for researching data and preparing reviews on articles that would allow the team to properly present their ideas during board meetings.
● Assisted the team in developing a location database for a new application. Involved reaching out to multiple organizations to see if they fit the guidelines of the app.
● Provided detailed transcriptions of focus group dialogue.
BioMarin Pharmaceuticals, San Rafael, CA - Data Management Assistant/TMF Administrator
June 2015 -July 2016
● Tracked progress of the individual trials, and own personal progress, using Excel spreadsheets
● Participated in biometrics systems User Acceptance Testing (UAT) for new trial development.
● Usage of GCP and GLP regulations associated with the maintenance and retention of clinical trial documentation and pre-clinical study records.
● Quality checks on both electronic and paper documents submitted to the records room and within the CTMS
● Managed a TMF Content list and TMF comprehensive review tracker.
● Fulfilled customer requests for retrieval, reproduction, and
re-filing of records or their electronic copies (pdf).
● Scanned, filed, sorted, separated, photocopied, printed, indexed, and
distributed both labels and files, of a variety of clinical study
records/documents in accordance with SOP mandated timelines.
● Supported inspection and audit preparation activities by providing access to documents across multiple sites, while keeping track of what department had them, as well as when and where they should
● Assisted with the identification and correction of errors for
documents within the VeevaVault system before FDA inspections.
● Maintained an efficient system for storing documents both internally and externally. Strong communication line to
offsite locations & personnel
Additional experience includes: Abercrombie & Fitch, Tilly’s, The Cheesecake Factory, Wine Bar
Columbia University, New York, NY - Bachelor's Degree Present
Business and Psychology major
Berkeley City College, Berkeley, CA - Associate’s Degree August 2016 - December 2018
pharma, clerical, data entry, administrative support, office support, legal