Kelly Tong
Dublin,CA
Summary
Clinical research associate with extensive experience at Abbott Diabetes Care, specializing in clinical trial management and regulatory compliance. Demonstrated success in leading teams to improve data integrity and operational efficiency. Proficient in ICH guidelines and site monitoring, with a strong focus on training and mentoring junior staff.
Overview
1
1
Certification
14
14
years of professional experience
Work History
Clinical Research Associate III
Abbott Diabetes Care
Alameda, CA
09.2024 - Current
- Performs study site visits (SIV, IMV, COV), ensuring compliance to the Study Protocol, Good Clinical Practices, ICG guidelines, Federal Regulations, department procedures and applicable regulatory requirements, generating monitoring trip reports, and track resolution of action items.
- Ensures quality delivery of study deliverables within agreed budgets and timelines
- Maintains and audit Trial Master File to ensure inspection readiness.
- Collaborated with clinical sites to consolidate and harmonize delegation codes, enhancing operational efficiency across multiple sponsors.
- Train junior CRAs on study conduct from site qualification, initiation, monitoring, close out and data clean up.
Clinical Research Associate II
Abbott Diabetes Care
Alameda, CA
07.2021 - 09.2024
- Managed all components of clinical trial, including study start up, site monitoring, and oversight of site personnel to ensure compliance and protocol adherence.
- Developed SIV presentations, ICFs, monitoring plan, source documents, case report forms, training logs, subject materials, and other essential items for clinical trial conduct.
- Communicated cross-functionally with Data Management, SAS Programming, Research and Development, and Systems Engineering to support successful completion of clinical trials from setup to archival.
- Negotiated study contracts and budgets with potential investigators. Amended current budgets.
- Contributed to the SME group for the eTMF system, Veeva, facilitating communication of updates and changes to the clinical team.
- Contributed to the HR New Hire Buddy program by assisting new hires in adjusting smoothly to their new role and company culture.
Clinical Research Associate I
Abbott Diabetes Care
Alameda, CA
09.2019 - 07.2021
- Ensured regulatory and clinical protocol compliance for assigned clinical projects by assisting in development of study-related materials and study start-up documents.
- Coordinated startup and maintenance of clinical study sites; reviewed and analyzed data and documents for accuracy and completeness while creating and processing data queries.
- Assisted in preparation, follow-up, and resolution of findings from monitoring visits and audits; reviewed and processed product complaints and adverse events promptly upon reporting.
- Device Accountability: Prepares shipments of investigational and/or marketed devices and study consumables. Track all chain of custody throughout the conduct of the study.
Clinical Trial Assistant II
Roche Diagnostics
Pleasanton, CA
04.2019 - 09.2019
- Subject matter expert for logistics of study material management in Clinical Trial Management System (CTMS). Working cross-functionally to create training modules.
- Served as department point of contact for third party long term storage of clinical materials, ensuring compliance with regulatory guidelines while coordinating pick up from clinical sites, sorting, indexing, and monitoring retention periods of documents.
- Managed analyzer inventory and quality control of existing instruments, coordinated refurbishment with manufacturing, and purchased new point of care instruments for clinical diagnostic trial. Executed quality control procedures and tracked shipment of over 200 point of care analyzers for pharmaceutical companion trial.
Clinical Trial Assistant I
Roche Diagnostics
Pleasanton, CA
07.2017 - 04.2019
- Oversaw logistical transit of 16 patient sample types from ten collection sites to five testing sites throughout trial, ensuring all sample shipping logs complied with GCP/GDP guidelines.
- Manage shipping and receiving, all study reagents, consumables, and materials in house across different study lifecycles and departments and through third party vendors in accordance to DOT, IATA, and local and federal regulations.
- Collaborate with InHouse and CRO CRAs remote monitoring ensuring document completeness throughout the trial and at study close.
- Created study/site regulatory/data binders and maintained clinical documents in electronic Trial Master File while providing technical support and conducting audit checks.
- Provided logistical support to clinical operations by creating purchase orders, printing labels, and shipping supplies while developing paper and electronic trial master files.
- Adhere to compliance in reporting cash and in-kind payments according to Sunshine Act.
Clinical Trial Assistant
Theranos, Inc.
Palo Alto, CA
01.2017 - 07.2017
- Established and managed clinical operations documentation and reports for clinical trials, including trial master files (TMF) and case report forms (CRF), ensuring compliance and accessibility.
- Maintained tracking and calibration of clinical trial consumables and equipment, supporting uninterrupted trial operations.
- Coordinated requests from patients, clinicians, and payers for patient information and laboratory data, facilitating effective communication and support.
Clinical Research Study Coordinator
Theranos, Inc.
Palo Alto, CA
01.2016 - 01.2017
- Trained a team of 20 phlebotomists to conduct a large-scale study enrolling 1500 patients in clinical trials across three sites, while managing staff activity logs and medical device usage.
- Planned and executed clinical IRB studies and research projects for assay and hardware development, resulting in successful scientific publication and regulatory submissions.
- Coordinated design and setup of collection site in satellite office, including stations, consumables, and equipment for efficient specimen collection, processing, and courier pickup.
- Created study enrollment binders and reorganized 9 months of backlogged R&D data, enhancing data recovery processes.
Senior Phlebotomist
Theranos, Inc.
Palo Alto, CA
07.2015 - 01.2016
- Scheduled and supervised phlebotomists conducting internal R&D studies with varying research protocols across multiple sites to ensure accurate capillary and venous collection, quality specimen processing, and successful tracking of study data.
- Trained new phlebotomists on patient service center operations, enhancing skills in patient care, software workflows, sample processing, inventory management, and courier interactions.
- Conducted mobile specimen collection at patients' homes, obtaining and processing specimens while coordinating customer service and managing collection materials and courier logistics.
Phlebotomist
Theranos, Inc.
Palo Alto, CA
08.2013 - 07.2015
- Managed operations at patient service center in Walgreens, collaborating with retail staff to enhance customer care, collecting and processing specimens, and overseeing supply inventory.
- Executed research studies by collecting venous capillary and urine samples, ensuring adherence to research protocols and workflows.
- Represented Theranos to patients advocating for increased accessibility in lab diagnostics.
- Performed VIP demonstrations with executive team board members and media staff.
- Developed requirements for proprietary software application to streamline scheduling of research studies and donor registration.
Contract Technician
Spectra Labs
Milpitas, CA
04.2013 - 06.2013
Education
Phlebotomy Certification, CPT-1 -
DeAnza College (EXPIRED)
San Jose, CA06-2012
Bachelors - Public Health Science
University of California, Irvine
Irvine, CA12-2010
Skills
- eTMF: Veeva
- Microsoft Office: Excel, Word, PowerPoint, Teams
- EDC: OpenClinica
- CTMS: RealTime, CRIO, Florence
- AirTable
Certification
Certified Clinical Research Associate (CCRA), Association of Clinical Research Professionals (ACRP), 05/25, Present
Accomplishments
- Divisional Vice Presidents Award of Excellence Q4 2023
- Divisional Vice Presidents Award of Excellence Q2 2025
Timeline
Clinical Research Associate III
Abbott Diabetes Care
09.2024 - Current
Clinical Research Associate II
Abbott Diabetes Care
07.2021 - 09.2024
Clinical Research Associate I
Abbott Diabetes Care
09.2019 - 07.2021
Clinical Trial Assistant II
Roche Diagnostics
04.2019 - 09.2019
Clinical Trial Assistant I
Roche Diagnostics
07.2017 - 04.2019
Clinical Trial Assistant
Theranos, Inc.
01.2017 - 07.2017
Clinical Research Study Coordinator
Theranos, Inc.
01.2016 - 01.2017
Senior Phlebotomist
Theranos, Inc.
07.2015 - 01.2016
Phlebotomist
Theranos, Inc.
08.2013 - 07.2015
Contract Technician
Spectra Labs
04.2013 - 06.2013
Phlebotomy Certification, CPT-1 -
DeAnza College (EXPIRED)
Bachelors - Public Health Science
University of California, Irvine