Pauline Luong-Carbajal Email and Phone Number
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Clinical research professional skilled in site management, EDC setup and data monitoring and management, remote/central monitoring, study start-up, project management, vendor qualification and management, patient recruitment, recruitment strategies, development of recruitment materials; and writing study documents including protocols, procedures, and consent forms.Clinical Trial Software Experience: CastorEDC, VeevaVault, REDCapCloud, MedrioProject management and Operational tools: Asana, monday.com, Google Suite, Office SuiteTherapeutic Areas/Study Type Experience: oncology IVD, low risk medical device, infectious disease IVD, biospecimen collection, skin infection pharmaceuticals, celiac disease (gastroenterology) pharmaceuticalsClinical Trial Phases: pre-clinical through Phase 2BEducation: Cal and Aggie alumni that studied biomedical engineering/bioengineering, with a focus on biomaterials (polyethylene glycol hydrogels), biomechanics, engineering design, and drug and device development. Personal Traits: Excels at achieving project design goals promptly and at technical writing. A team player with outstanding communication skills, customer service skills, and attention to detail. Quick learner, resourceful, and adept at working on multiple projects in fast-paced environments.Fun Extras: Passionate about traditional and digital illustration and painting, which has been leveraged by clients to produce marketing brochures and flyers for clinical trial recruitment, tradeshows, business development, investor pitch decks, digital advertisements, and print advertisements. Lifetime learner that engages in continual self-improvement through clinical research education, marketing & design, enterprise software mastery, and community outreach.Loves to volunteer for clinical research organizations, animal welfare, food banks, STEM education, and social equality initiatives. Feel free to reach out if you need a helping hand anytime!
Advanced Clinical
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Clinical SpecialistAdvanced Clinical Feb 2024 - PresentDeerfield, Illinois, Us
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Clinical Project ManagerGlobal Bioclinical Nov 2023 - PresentSeattle, Wa, Us -
Clinical Research AssociateGlobal Bioclinical Jan 2018 - Nov 2023Seattle, Wa, UsAdvanced from Clinical Trials Operations Assistant to CRA role after just 5 months of proven work. In addition to responsibilities from previous role:• Site management from qualification to IRB submissions to monitoring for IVD trials.• Coordinates biospecimen collection and shipping operations for IVD trials.• Oversees data quality and management for select sample collection studies.• Develops electronic CRFs to increase efficiency of data collection.Select accomplishments include:• Co-monitored on-site one of the largest regional health systems on the East Coast and verified consent and eligibility, completion of critical CRF data, discrepancies between EPIC EMR and Medrio database.• Implemented changes in procedures, trackers, and EDC with thorough documentation to eliminate inefficiencies in sample and data delivery feedback between site, sponsor, and CRO.
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Clinical Research Operations AssistantGlobal Bioclinical Jul 2017 - Jan 2018Seattle, Wa, Us• 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.
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Founder & ConsultantCreative Clinical R&D Llc May 2017 - PresentManagement and operational support for low risk medical device and IVD studies from site qualification, site initiation, document and forms creation to recruitment, monitoring, and close-out. *See positions at employers below within this date range for specific titles, responsibilities and achievements.Key responsibilities have included:• Participating in study design and execution• Tracking, maintaining, and ensuring timely delivery of study and regulatory documentation• Review, select, and liaise with external vendors• Follow and comply with established SOPs, GCP and regulatory requirements• Manage, review and track investigational product production and shipment, study supplies, and study data• Participate in and lead study monitoring visits (remote and on-site)• Interpret and implement FDA regulations and NIH policies• Select, manage and oversee external vendors• Coordinate and participate in clinical meetings between Sponsors, research sites, IRBs, and business partners• Develop company and clinical trial-specific marketing materials (e..g, recruitment flyers, websites, pre-screening questionnaires)• Monitor and provide assistance to site enrollment • Configure software and systems into useful clinical trial platforms and tracking tools for Sponsor and sites• Write study reports and technical papers -
Clinical Trials Patient Recruitment SpecialistImmunogenx Apr 2018 - Sep 2023Hired as a consultant to advise on patient recruitment strategy and design recruitment processes and advertising materials. Involved closely with the sites, vendors, and patient advocacy groups to track and optimize enrollment. Key Achievements:• Developed enrollment screening process and hired highly competent employees to conduct screening, leading to >50% of sites’ enrollment and directly enabled study completion.• Implemented a patient reimbursement system that saves the sponsor 90% in total costs compared to industry vendor costs.• Hired and managed multiple contract associates to support the screening of online leads for study enrollment.
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Clinical Trial ManagerPressure Profile Systems Jan 2016 - Apr 2017Glasgow, Scotland, GbManaged 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 CoordinatorPressure Profile Systems Sep 2015 - Dec 2015Glasgow, Scotland, Gb• 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.
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Product SpecialistIngeneron Incorporated Sep 2014 - Apr 2015Houston, Tx, Us• 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 InternIngeneron Incorporated Jun 2014 - Aug 2014Houston, Tx, Us• 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.
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PresidentSociety For Biomaterials, Texas A&M Student Chapter Aug 2013 - May 2014College Station, Tx, Us• 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 LiaisonSociety For Biomaterials, Texas A&M Student Chapter May 2013 - May 2014College Station, Tx, Us• 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.
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Graduate Research AssistantCosgriff-Hernandez Lab Aug 2012 - Oct 2013Development of biostable and bioactive hydrogels for use in small diameter multilayer vascular grafts
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Bioe101 NotetakerConolly Lab, Uc Berkeley Jan 2012 - May 2012Compiled and organized key points from lecture into Powerpoint presentations for future lecturers to reference and/or use.
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Research InternTexas A&M University Jun 2011 - Aug 2011College Station, Tx, Us10-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.
Pauline Luong-Carbajal Skills
Pauline Luong-Carbajal Education Details
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University Of California, BerkeleyBioengineering And Biomedical Engineering -
Texas A&M UniversityBioengineering And Biomedical Engineering
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Irvine Valley College
Frequently Asked Questions about Pauline Luong-Carbajal
What company does Pauline Luong-Carbajal work for?
Pauline Luong-Carbajal works for Advanced Clinical
What is Pauline Luong-Carbajal's role at the current company?
Pauline Luong-Carbajal's current role is Certified Clinical Research Professional (ACRP-CP) | Experienced in Clinical Trial Operations, Site Management, Data Management, Patient Recruitment & Marketing | BioEngineer, Berkeley / TAMU.
What is Pauline Luong-Carbajal's email address?
Pauline Luong-Carbajal's email address is pl****@****amu.edu
What schools did Pauline Luong-Carbajal attend?
Pauline Luong-Carbajal attended University Of California, Berkeley, Texas A&m University, Irvine Valley College.
What are some of Pauline Luong-Carbajal's interests?
Pauline Luong-Carbajal has interest in Orthopedic Biomechanics, Cooking And Baking, Writing And Drawing, Biomaterials, Health, Event Planning, Education, Environment, Dancing, Science And Technology.
What skills is Pauline Luong-Carbajal known for?
Pauline Luong-Carbajal has skills like Biomedical Engineering, Solidworks, Photoshop, Cell Viability Assays, Cell Culture, Biomaterials, Matlab, Business Management For Engineering Certificate, Illustrator, Visio, Comsol, Microsoft Office.
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