Amy Minshall, Aboc Email and Phone Number
Steering clinical trials at Topcon Healthcare, my focus lied in ensuring precision and compliance through rigorous adherence to ALCOA-CCEA practices and IRB regulations. With a commitment to excellence, our team adeptly managed investigational device inventories and maintained up-to-date regulatory binders.My expertise in Electronic Data Capture systems like Medidata, combined with extensive experience in clinical research coordination, empowered us to efficiently recruit and educate sites. We are dedicated to advancing ophthalmic care and contributing to the development of innovative treatments that improve patient outcomes.
Thermo Fisher Scientific
View- Website:
- thermofisher.com
- Employees:
- 99360
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Clinical Research ManagerThermo Fisher ScientificLas Vegas, Nv, Us -
Clinical Trial ManagerTopcon Healthcare Aug 2023 - May 2024La Jolla, Ca• Developed device training documents based off device user manual, protocol, and hands-on training from engineers.• Used completed training documents to conduct staff training sessions at SIVs after installing the investigational device on-site.• Facilitated shipping/receiving and importing/exporting of investigational devices to/from sites and headquarters.• Contributed to drafting CRFs, revised (CRF completion, GCP, and GDP) training decks, and SOPs and also created supplemental form templates for SOPs.• Prepared regulatory binders for sites by collecting current credentials from all site staff and provided protocol specific documents (including copies of user manuals for investigational and comparator devices, training documents, training decks used at SIV for training sessions, blank CRFs, logs, etc.)• Created and maintained eTMF for all studies.• Conducted routine monitoring and audits for in-house feasibility studies to ensure adherence to GCP and ICH guidelines, protocol, and GDP.• Identified potential study sites for future projects and contributed to proofreading Clinical Study Reports.• Maintained inventory of gift cards for subject compensation. -
Clinical Research CoordinatorScripps Poway Eyecare Jun 2017 - Aug 2023• Managed subject recruitment, conducted informed consent, and conducted study procedures.• Maintained all logs (enrollment, informed consent, ICF version, device accountability, IP accountability, AE, calibration, training, DOA, and PD) to ensure completeness and accuracy.• Completed source documents according to GDP and ensured data entry into EDC was completed in a timely manner.• Responded to queries in EDC.• Acted as liaison between site, sponsor, and CRO and was present for all IMVs with CRAs to provide clarification and any corrections needed.• Maintained inventory of investigational products and investigational devices.• Ensured Regulatory Binder was up to date with all current credentials and training along with all correspondence between site and CRO, sponsor, and/or IRB.• Trained other study coordinators.• Created source documents and SOPs for site implementation.
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Lead OpticianGordon Schanzlin New Vision Institute May 2015 - Jun 2017San Diego, Ca• VSP, MES, and EyeMed billing as well as obtaining VSP, MES, and EyeMed authorizations• Frame selection with patients based on lifestyle dispensing and patient education• Teaching patients how to insert, remove, and maintain contact lenses (soft, hard, scleral, and SynergEyes)• Verifying prescriptions received from outsourced labs and handling returns of lab remakes• Monitoring jobs in process at the lab to ensure accurate and timely delivery• Pre-testing patients using OCT iWellness and anterior seg, FDT, Optos, Annidis, and topography and Pentacam when necessary
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WriterCover32 Aug 2014 - Feb 2017Remote, United States• As one of the two primary writers covering the Oakland Raiders for Cover32, I delivered in-depth analysis, breaking news updates, and game recaps.• Regularly conducted radio, vlog, and podcast interviews to discuss the Raiders and promote Cover32's coverage.• Provided real-time in-depth coverage on the Raiders' draft picks to provide readers with the rookies’ backgrounds.• Worked closely with the managing editor to produce two articles per week or more dependent upon time of year.• Some of my Cover32 articles are still featured on Yahoo Sports. -
Optical ManagerGlobal Laser Vision Oct 2013 - Apr 2015San Diego, Ca-Maintaining frame inventory-Fitting patients according to lifestyle dispensing-Contact lens trainings-Verifying accuracy of prescriptions created at outside labs
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WriterSports Fan News Jan 2013 - Aug 2014Remote, United States• Created content for the Sports Fan News blog, focusing on the Oakland Raiders from a passionate fan's perspective.• Increased blog traffic through engaging articles and active social media promotion.• Worked closely with a content editor and managing editor to produce one article per week.
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Lab ManagerFamily Vision Care Jul 2011 - Oct 20134310 Genesee Avenue #101 San Diego, Ca 92117-Performed pre-testing for patients including auto-refraction, non-contact tonometry, Optos retinal imaging, topography, OCT and FDT.-Frame style using lifestyle dispensing-Contact lens trainings-Edged SV, FT, TF, and PAL lenses on Santinelli Lex 1000 with ICE Mini+ CAD blocker-Verified prescriptions received from outside labs-Monitored accuracy and timely delivery of jobs returning from outside labs-Maintained stock of lens blanks-Acted as patient care coordinator for Lasik patients at Gordon Weiss Schanzlin Vision Institute
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Research Associate Ii, R&DEbioscience Jan 2009 - Jul 2011-Chemical modification/activation of fluorescent molecules, antibodies, recombinant proteins, bioconjugation, and purification-Product stability and formulation-Transfer of process specifications and protocols to manufacturing -
Research Associate I, MicrobiologyPacira Pharmaceuticals, Inc. Sep 2008 - Dec 2008-Aseptic Class 100,000 gowning and environmental monitoring-Operated Met One particle counter, RCS air sampler, and slit to agar-Sampled water, nitrogen, clean steam, and clean compressed air (CCA) -Manufactured media (TSA, TSB,SAB broth, SAB agar, Fluid D, SDS, glycerin) -
Certified OpticianRichard Sarlitt, Od Aoc Aug 2003 - Sep 2008· Answered phones, booking appointments, and ordering contact lenses and eyeglass frames· Aided patients with frame selection and dispensing glasses· Taught patients how to insert, remove, and maintain contact lenses· Performed Humphrey visual fields, NCT, digital fundus photos, and auto-refraction
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Certified OpticianRxoptical Jun 2002 - Aug 2003· Answered phones and booked appointments· Aided patients with frame selection and dispensed glasses· Taught patients how to insert, remove, and maintain contact lenses
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OpticianMarshall Field'S Optical, A Us Vision Company Oct 2000 - Jun 2002· Answered phones and booked appointments· Aided patients with frame selection and dispensed glasses· Taught patients how to insert, remove, and maintain contact lenses· Verified prescriptions of incoming lab orders before dispensing
Amy Minshall, Aboc Education Details
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Biology With A Concentration In Cell And Devlopmental Biology
Frequently Asked Questions about Amy Minshall, Aboc
What company does Amy Minshall, Aboc work for?
Amy Minshall, Aboc works for Thermo Fisher Scientific
What is Amy Minshall, Aboc's role at the current company?
Amy Minshall, Aboc's current role is Clinical Research Manager.
What schools did Amy Minshall, Aboc attend?
Amy Minshall, Aboc attended California State University, Fullerton.
Who are Amy Minshall, Aboc's colleagues?
Amy Minshall, Aboc's colleagues are Virginie P. Lavallée, Tonya Jarrett, Ronen Levi, Thiru Thamo, Iain Chalmers, Reham Mahmoud, Narasimha Shenoy.
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