Pauline Luong-Carbajal Email & Phone Number

Deerfield, Illinois, US

Seattle, WA, US

Seattle, WA, US

• Advanced 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.

Seattle, 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.
• 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.
• 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.

• Management 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.
• 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

• Hired 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.
• 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.

Glasgow, Scotland, GB

• 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.

Glasgow, 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.

Houston, 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.

Houston, 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.

College 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.

College 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.

Development of biostable and bioactive hydrogels for use in small diameter multilayer vascular grafts

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

College Station, TX, US

• 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.
• 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.

Bachelor Of Science (Bs), Bioengineering And Biomedical Engineering

Masters Of Engineering, Bioengineering And Biomedical Engineering

Education record