Experience

Global BioClinical

• United States
• Biotechnology
• 1 - 100 Employee

• Clinical Research Operations Assistant

  • Jul 2017 - Jan 2018

  Issaquah, Washington, United States • Supported site management and study operations through regular communication with sites to hold sites accountable to deliverables, identify any quality or supply concerns, and relay updates to CRO director and study sponsors. • Obtained and coordinated documents from sponsors and sites for IRB submissions and reviews. Identified and qualified sites and vendors, including review of contracts, budgets, facilities, personnel qualifications, and experience. • Initiated study startup… Show more • Supported site management and study operations through regular communication with sites to hold sites accountable to deliverables, identify any quality or supply concerns, and relay updates to CRO director and study sponsors. • Obtained and coordinated documents from sponsors and sites for IRB submissions and reviews. Identified and qualified sites and vendors, including review of contracts, budgets, facilities, personnel qualifications, and experience. • Initiated study startup, including preparation of SIV materials, transfer of initial TMF documents, shipment of supplies, and training of site personnel. Select Achievement: • Coordinated the consistent collection and tracking and then the successful delivery of 3,500+ biospecimen samples from 18 US sites to Germany for infectious disease IVD research studies. Show less



Pressure Profile Systems

• Clinical Trial Manager

  • Jan 2016 - Apr 2017

  Greater Los Angeles Area Managed a single-site, single-arm pilot clinical trial for Class I exempt medical device from initiation through close-out: • Led patient screening, recruitment, and data collection. • Maintained the investigator and trial binders. • Managed relationships, communication, and documents between site, sponsor, vendors, and regulatory authorities (IRBs, HHS, NIH) • Trained and managed conduct of site personnel according to protocol and applicable regulations. • Created… Show more Managed a single-site, single-arm pilot clinical trial for Class I exempt medical device from initiation through close-out: • Led patient screening, recruitment, and data collection. • Maintained the investigator and trial binders. • Managed relationships, communication, and documents between site, sponsor, vendors, and regulatory authorities (IRBs, HHS, NIH) • Trained and managed conduct of site personnel according to protocol and applicable regulations. • Created spreadsheet-based tracking methods to monitor and analyze PRO data and test results. • Audited binders and CRFs regularly for completeness and accuracy. • Designed flyers, website, and other patient-facing materials for recruitment, education, and study conduct. Project planning for an SBIR Phase II grant involving human subjects research: • Designed and developed study protocols, SOPs, data collection tools and workflow, and advertisements. • Advanced the design, conduct, and close-out of in vitro and in human research studies with imaging centers, large health systems, small independent clinics, and large academic research institutions. • Qualified and set up clinical research services, sites, and EDC systems for the multi-site, placebo-controlled RCT. • Conducted data QC and analysis and completed study reports per sponsor and HHS/SBIR requirements.

• Assistant Clinical Trial Coordinator

  • Sep 2015 - Dec 2015

  Los Angeles, CA • Liaised between sponsor, study site PI, and CRO consultant. • Enabled the successful relaunch of a stalled study by revising the entire clinical protocol, CRFs and logs, and coordinating submission to the IRB. • Worked with PI to prepare site and with sponsor to prepare study supplies.



InGeneron Incorporated

• Product Specialist

  • Sep 2014 - Apr 2015

  Houston, TX • Drove the development of one product through design phase to pre-market phase. • Interfaced with multiple suppliers and contract manufacturers to obtain desired products/services, address nonconformities or design issues, and update shared documents. • Performed incoming inspections on critical and non-critical components, including MRP tracking and disposition. • Initiated and resolved non-conforming material reports and CAPA’s. • Created and maintained various engineering… Show more • Drove the development of one product through design phase to pre-market phase. • Interfaced with multiple suppliers and contract manufacturers to obtain desired products/services, address nonconformities or design issues, and update shared documents. • Performed incoming inspections on critical and non-critical components, including MRP tracking and disposition. • Initiated and resolved non-conforming material reports and CAPA’s. • Created and maintained various engineering, production, and quality documents, including SOPs, product labels, engineering drawings, QMS documents, product IFUs, design history file documents. • Assisted in internal and external audit preparation. • Assisted in tissue and cell preparation and animal maintenance. • Developed marketing/advertising brochures according to regulatory and company requirements.

• Regulatory Affairs/Quality Assurance Intern

  • Jun 2014 - Aug 2014

  Houston, TX • Assisted in defining regulatory classification, preparing documentation, and reviewing submissions of 510(k) applications and Technical Files. • Advanced product through design and development phases, which included developing required documents for the Technical File and meeting with team members to make critical decisions. • Assisted in validation testing of new software on products. • Designed appealing and compliant marketing materials, including product catalogs, newsletters… Show more • Assisted in defining regulatory classification, preparing documentation, and reviewing submissions of 510(k) applications and Technical Files. • Advanced product through design and development phases, which included developing required documents for the Technical File and meeting with team members to make critical decisions. • Assisted in validation testing of new software on products. • Designed appealing and compliant marketing materials, including product catalogs, newsletters, and promotional material.



Society for Biomaterials, Texas A&M Student Chapter

• President

  • Aug 2013 - May 2014

  Texas A&M University, College Station, TX • Headed the Texas A&M University Student Chapter of Society for Biomaterials (SFB). • Planned, organized, and executed academic and professional events to expose members to past and current biomaterials research. • Oversaw duties and performance of 5 officers, established and maintained relations with academic and industry professionals, and promoted member retention. • Encouraged the involvement of students in biomaterials research at A&M and in the activities of the national SFB… Show more • Headed the Texas A&M University Student Chapter of Society for Biomaterials (SFB). • Planned, organized, and executed academic and professional events to expose members to past and current biomaterials research. • Oversaw duties and performance of 5 officers, established and maintained relations with academic and industry professionals, and promoted member retention. • Encouraged the involvement of students in biomaterials research at A&M and in the activities of the national SFB group.

• Biomedical Engineering Guest Liaison

  • May 2013 - May 2014

  College Station, TX • Act as liaison between Administrative Coordinator and Advisor and the BMEN student ambassadors to organize lab tours for visiting faculty, invited speakers, and K-12 student groups. • Organized volunteers to serve on lab tours and ensured involved members were confirmed of time and location.



Cosgriff-Hernandez Lab

• Graduate Research Assistant

  • Aug 2012 - Oct 2013

  Texas A&M University Development of biostable and bioactive hydrogels for use in small diameter multilayer vascular grafts



Conolly Lab, UC Berkeley

• BioE101 Notetaker

  • Jan 2012 - May 2012

  Compiled and organized key points from lecture into Powerpoint presentations for future lecturers to reference and/or use.



Texas A&M University

• United States
• Higher Education
• 700 & Above Employee

• Research Intern

  • Jun 2011 - Aug 2011

  College Station, TX 10-week research internship with Dr Christopher Quick at the Michael E. Debakey Institute. • Constructed mathematical models of flow in dynamic lymphatic vessels and conducted experiments on bovine mesenteric lymphatic vessels to determine differential lymphangion pumping activity in response to different flow rates and profiles. • Discovered that lymphangions show a more pronounced decrease from steady flows to pulsatile flows when subjecting vessels to rates of 1 ml/min versus 0.1… Show more 10-week research internship with Dr Christopher Quick at the Michael E. Debakey Institute. • Constructed mathematical models of flow in dynamic lymphatic vessels and conducted experiments on bovine mesenteric lymphatic vessels to determine differential lymphangion pumping activity in response to different flow rates and profiles. • Discovered that lymphangions show a more pronounced decrease from steady flows to pulsatile flows when subjecting vessels to rates of 1 ml/min versus 0.1 ml/min. Show less