High-energy Clinical Research Associate with extensive laboratory, technical training, and customer facing experience. Talents include excellent interpersonal and organizational skills, knowledge of ICH, GCP, and FDA guidelines, and strong problem-solving skills.
Teamwork Award 2017 –Assisted with bridging
gap between newly established departments Clinical Affairs and Clinical
Consistent training evaluation scores with
>4 out of 5 max within the Training and Field Service Support departments
CAPP President's Award 2013 – Nominated by
the Brisbane team for the CARDSCAN training I developed
CAPP Team Impact Award 2012 – Completed
assay and FDA submission for the NeoPlex assay
R&D Award 2011 –Initial assay
development team that contributed to NeoPlex development and validation
09/2016 to Current
Clinical Research Associate IILuminex Corporation － Austin, TX
04/2015 to 09/2016
International Field Service EngineerLuminex Corporation － Austin, TX
Globally trained approximately ten new and existing Field Service Engineers a month on Luminex software, instruments, maintenance, and troubleshooting.
Developed multi-level classroom courses and videos to accommodate trainees with varying levels of knowledge which provides a "stepping stone" training path.
Assisted with development of training materials, technical/troubleshooting guides, software manuals, and new product release presentations.
Subject matter expert for ARIES and M1 which include handling issues for instrument parts, troubleshooting, diagnostics and repairs.
Represented Americas and EMEIA regions in order to communicate field concerns, advisories, and solutions to continue day-to-day business.
Maintained field service cases and Luminex Learning training tasks within salesforce.com.
Trained new and existing employees, partners, and customers on Luminex software, instruments, assay development (including applications in immunoassay and nucleic acid development) and diagnostic assay kits.
This included general product use, maintenance, troubleshooting, assay optimizations, technical tips, etc.
Developed multi-level classroom courses, technical/troubleshooting guides, handouts, and new product release presentations.
Collaborated with project managers, systems integration groups, and marketing and sales personnel to determine training needs and content.
Created class courses, development plans, events, quizzes, and reports within online CRM module.
Proficient in Power Point, Adobe Connect, WebEx, Storyline, Audition, Photoshop, and salesforce.com.
01/2009 to 12/2012
Associate Research & Development Scientist ILuminex Corporation － Austin, TX
Executed research and development projects to improve methods of current analysis special to abnormal blood test results regarding metabolic and genetic disease.
Assisted with clinical trial commencement of newborn screening kit.
Integrated assays using TECAN automated robotic systems, BSD semi-automated puncher, Luminex 200 analyzer, MAGPIX, xPONENT software, and xPONENT QC.
Head trainer to new employees, marketing personnel, and client site operators of assay with two different desk-top systems.
Complied with GMP, GLP and FDA regulations within a BSL-II lab environment.
Worked closely with Manufacturing, QC, and QA groups to create and revise lab protocols, manufacturing instructions, product specifications and acceptance criteria to meet FDA requirements with project advancement.
Participated in APHL Newborn Screening Symposiums by scientific poster submissions, system demonstrations, and customer interaction.
07/2008 to 11/2008
Chemist IIPharmaForm － Austin, TX
Performed testing that included bulk uniformity, appearances, assays, dose content uniformity, related substances, and aerodynamic assessment of fine particles.
Competent with HPLC and Empower2 software.
Oversaw method qualification and validation of projects requiring approval for in-house transfer testing.
07/2006 to 06/2008
Assistant Scientist IIAAIPharma － Wilmington, NC
Performed GC testing of raw materials, in-process and finished product samples implementing USP, EP, JP, and client provided testing procedures in GMP and GLP environment.
Executed method validations for client products specializing in GC and TLC techniques.
Proficient in general wet chemistry techniques including titrations, FTIR, KF, TLC and UV-Vis Spec, and Millennium 2 software.
Implemented reagent logbook system for compendial testing group, carried out GMP review of projects, and revised testing procedures.
Participated in employee process improvement committee dedicated to improve lab safety skills and education, arrange for training seminars, request lab equipment and testing supplies, and organize employee socials.
Medical First Responder certified.
Education and Training
Bachelor of Science: BiologyUniversity of North Carolina WilmingtonCo-author of paleoecology paper published in Journal
of Biogeography, Vol 42, Issue 3, Packrat
middens and the Holocene palaeohistory of Colorado piñon (Pinus edulis)
in western Colorado (pages 565–574).
Activities and Honors
Teamwork Award 2017 -Assisted with bridging gap between newly established departments Clinical Affairs and Clinical Operations
* Consistent training evaluation scores with >4 out of 5 max within the Training and Field Service Support departments
* CAPP President's Award 2013 - Nominated by the Brisbane team for the CARDSCAN training I developed
* CAPP Team Impact Award 2012 - Completed assay and FDA submission for the NeoPlex assay
* R&D Award 2011 -Initial assay development team that contributed to NeoPlex development and validation