Experience

Hologic (Formerly Gen-Probe)

• United States
• Biotechnology Research
• 300 - 400 Employee

• Clinical Trial Lead

  • Aug 2022 - Present

  San Francisco Bay Area



Cepheid

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Clinical Research Associate

  • Mar 2022 - Jun 2022

  Sunnyvale, California, United States

• Clinical Research Associate II

  • Mar 2020 - Feb 2022

  Sunnyvale, California, United States Cepheid employees are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. Cepheid works alongside a community of six fellow… Show more Cepheid employees are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. Cepheid works alongside a community of six fellow Danaher Diagnostics companies to address the world’s biggest health challenges, driven by knowing that behind every test, there is a patient waiting. My duty as a Clinical Research Associate plays an integral role in the planning and execution of clinical trials in addition to the management of clinical trial sites to ensure compliance with SOPs, protocols, FDA, ICH, and other applicable regulations. I had the opportunity to independently train, manage, and monitor external clinical sites, vendors, academic institutions and CROs (outside of U.S.) participating in studies, from site identification through study closeout, identify and suggest solutions to resolve problems or issues which could affect the integrity of the data or timely completion of the clinical study, create case report forms, perform user acceptance testing and facilitate the execution of edit check specifications, responsible for the generation of study documents, project files and other study materials, participate in process improvements, assist in study planning and preparation including but not limited to timelines, study plans, budgets, clinical templates (I.e. ICFs.), support clinical lead with study tracking and key performance indicators to ensure deliverables are met on time.



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Associate II

  • Aug 2019 - Feb 2020

  Remote - Home based in the Santa Clara Area IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. My duties as a Clinical Research Associate II at IQVIA include but not limited to: conducting on-site… Show more IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. My duties as a Clinical Research Associate II at IQVIA include but not limited to: conducting on-site initiation, interim (routine) monitoring and close out visits for 20+ sites with 10+ different protocols in various therapeutic areas including indications in diabetes and skin diseases, building and maintaining good rapport with site staff and sponsor staff while promoting a collaborative working relationship, managing and maintaining information and documentation in CTMS, eTMF, and various other systems as appropriate and per timelines, mentoring and sharing best practices with new hires as appropriate, etc Show less



Hologic (Formerly Gen-Probe)

• United States
• Biotechnology Research
• 300 - 400 Employee

• Clinical Research Associate

  • Jun 2018 - Aug 2019

  Greater San Diego Area Hologic was founded in 1985 and is headquartered in Marlborough, Massachusetts. Our company engages in the development, manufacture, and supply of diagnostics products, medical imaging system, and surgical products dedicated to serve the healthcare needs of women. It operates through the different business segments: Breast Health, Diagnostics, Medical Aesthetics, GYN Surgical, and Skeletal Health. My duties and responsibilities include but not limited to: performing independent clinical… Show more Hologic was founded in 1985 and is headquartered in Marlborough, Massachusetts. Our company engages in the development, manufacture, and supply of diagnostics products, medical imaging system, and surgical products dedicated to serve the healthcare needs of women. It operates through the different business segments: Breast Health, Diagnostics, Medical Aesthetics, GYN Surgical, and Skeletal Health. My duties and responsibilities include but not limited to: performing independent clinical site visits for 3-4 ongoing IVD trials (Qualification, Initiation, Interim Monitoring and Close-out visits) for collection and testing sites, preparing accurate site visits reports and communicate with site staff to ensure the completion of pending actions and resolutions of study conduct issues, assisting with the creation, development and management of clinical study documents (case report forms, informed consent forms, enrollment tracking, device accountability, source documents, etc), participate in the training and management of external vendors and sometimes CRO teams, investigator and staff and mentoring junior clinical staff members on monitoring activities, assisting with the execution of clinical studies to ensure study deliverables are completed on time and within budget, etc.

• Clinical Trial Assistant

  • Jul 2017 - Jun 2018

  Greater San Diego Area As a Clinical Trial Assistant, I am responsible for providing support to the clinical study manager and study management team, clinical tracking and document maintenance as applicable to study vendors and clinical trial sites. From study start up to study close, I work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in compliance with our company's SOPs, ICH/GCP/regulatory guidelines, company goals and budgets. Some of my essential… Show more As a Clinical Trial Assistant, I am responsible for providing support to the clinical study manager and study management team, clinical tracking and document maintenance as applicable to study vendors and clinical trial sites. From study start up to study close, I work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in compliance with our company's SOPs, ICH/GCP/regulatory guidelines, company goals and budgets. Some of my essential duties include: obtaining, processing and tracking study related documents, maintaining and ensuring the completeness of the Trial Master File (TMF) in accordance with SOP requirements, going on co-monitoring visits, performing source document and ICF verifications, managing clinical samples with LIMS, creating meeting minutes, and managing and tracking Investigational Product supplies for study centers, etc



Comparative Neuromuscular Lab at UC San Diego

• Staff Research Associate II

  • Aug 2013 - Jun 2017

  Greater San Diego Area The Comparative Neuromuscular Laboratory located in the School of Medicine at the University of California, San Diego. This laboratory, established in 1990, is an international reference center dedicated to the diagnosis and study of spontaneous neuromuscular diseases in companion animals. The specialized testing performed in this laboratory includes evaluation of muscle and peripheral nerve biopsies by state-of-the-art methods, immunohistochemistry, immunofluorescence staining and… Show more The Comparative Neuromuscular Laboratory located in the School of Medicine at the University of California, San Diego. This laboratory, established in 1990, is an international reference center dedicated to the diagnosis and study of spontaneous neuromuscular diseases in companion animals. The specialized testing performed in this laboratory includes evaluation of muscle and peripheral nerve biopsies by state-of-the-art methods, immunohistochemistry, immunofluorescence staining and immunoblotting for the diagnosis of various muscular dystrophies and other congenital myopathies. Serological testing for acquired myasthenia gravis (acetycholine receptor antibodies) and for masticatory muscle myositis (2M antibodies) is also performed. Metabolic testing for inborn errors is performed in collaboration with the Biochemical Genetics Laboratory at UCSD. As a Research Associate at the Comparative Neuromuscular Laboratory, my daily work entails carrying out specialized radioimmuno-assays, performing data entry from medical records, analyzing and reviewing data generated by functional assays, preparing and releasing results, composing and incorporating SOPs, answering phone calls concerning testing procedures and result interpretation as well as providing training for new team members.

• Lab Assistant III

  • Jul 2011 - Jul 2013

  Greater San Diego Area

• Laboratory Assistant

  • Jun 2008 - Jun 2011

  Greater San Diego Area I was responsible for general laboratory maintenance including the preparation of solutions, buffers, substrates and incubating media for assays, organization and maintenance of a filing system for confidential patient records.



Think Together

• United States
• Education Administration Programs
• 700 & Above Employee

• Summer Program Leader

  • Jun 2011 - Aug 2011

  Greater San Diego Area THINK Together's mission is to create opportunities for all kids to discover their passions and reach their full potential. Since 1994, we have been improving academic outcomes for children and youth living in under-resourced communities. As a summer program leader, I acted as mentors, advisers and developmental guides to urban and under-served youth by delivering engaging lessons that align with classroom curriculum, empowering students to success academically and encouraging personal… Show more THINK Together's mission is to create opportunities for all kids to discover their passions and reach their full potential. Since 1994, we have been improving academic outcomes for children and youth living in under-resourced communities. As a summer program leader, I acted as mentors, advisers and developmental guides to urban and under-served youth by delivering engaging lessons that align with classroom curriculum, empowering students to success academically and encouraging personal growth. I also worked to build successful partnership with parents, teachers and the community. Show less



Vical

• United States
• Biotechnology
• 1 - 100 Employee

• Lab Technician

  • Jun 2009 - Aug 2011

  Greater San Diego Area Vical researches and develops biopharmaceutical products based on patented DNA delivery technologies for the prevention and treatment of serious and life-threatening disease. Our active independent and partnered development programs include infectious disease vaccines for use in high-risk population, cancer vaccines or immunotherapies, gene-based delivery of angiogenic growth factors for treatment of cardiovascular diseases. My duties as a Lab Technician was to provide support to… Show more Vical researches and develops biopharmaceutical products based on patented DNA delivery technologies for the prevention and treatment of serious and life-threatening disease. Our active independent and partnered development programs include infectious disease vaccines for use in high-risk population, cancer vaccines or immunotherapies, gene-based delivery of angiogenic growth factors for treatment of cardiovascular diseases. My duties as a Lab Technician was to provide support to scientists from the R&D, QC and QA departments. I had to keep a laboratory notebook following specific guidelines and adhere to safety regulations, lab SOPs, GLP, GCP and GMP. In addition to preparation of media and buffers, I also demonstrated the ability to perform laboratory techniques such as DNA purification, liquid chromatography, water purification analysis, formulation and HPLC. Show less



UCSD Department of Chemistry Undergraduate Laboratories

• Student Lab Assistant

  • Jul 2007 - Jan 2010

  My main job duties were to formulate experiment unknowns for students and set up controlled experiments and trials for TAs and professors to use as guidelines. I was also responsible for maintaining, calibrating, cleaning and testing sterility of equipment in multiple undergraduate laboratories.