Cathy Nguyen
Irvine
Summary
Results-driven Senior Clinical Operation Associate with expertise in clinical trial management and regulatory compliance. Enhances project workflows and stakeholder engagement to drive operational efficiency. Collaborates across functions to ensure timely execution of clinical studies while upholding quality standards. Focused on process improvement and excels in fast-paced environments.
Overview
20
20
years of professional experience
Work History
SENIOR CLINICAL OPERATION ASSOCIATE
Otsuka
01.2022 - Current
- Coordinated clinical operations for Otsuka clinical trials, ensuring compliance and efficiency across all phases.
- Support Study Management with day-to-day study and study-site administration activities throughout study lifecycle (start-up, execution, close-out)
- Serve as initial internal point of contact for assigned study sites and provide liaison support between study site, Field Monitor and Study Management
- Maintenance of applicable clinical systems data associated with study conduct
- Trial Master File and Essential Documents management
- Development of program specific standards (e.g., agendas, minutes, filing structure, team materials).
- Contracting and invoicing of key advisors/vendors/external service providers (ESPs)
- Creation and maintenance of databases or tracking tools
- Project coordination activities
- Clinical Inspection Readiness and Quality Management System activities (e.g., deviations and CAPAs)
- Ensured efficient resource distribution to meet project needs.
- Clinical audit/inspection activities as assigned
- Participate in the development, review, implementation and updating of key standard processes that lead to positive and measurable impact for clinical programs managed by the clinical management team (e.g., quality, efficiency, consistency)
- Assist with management of clinical systems updates, enhancements and master data stewardship as required
- Support coordination of project activities and liaise between global affiliates, external vendors, and clinical research teams as requested
- Serve as a resource to departmental personnel and external service providers in areas of expertise including applicable internal database and electronic systems applications (e.g., EDMS, CTMS, eTMF, legal databases, QMS, etc.) and process management (e.g., contracting, document management, etc.)
- Assists with the management of ESP counterparts and processes for vendors / external service providers / contract personnel implementing program level activities specific to assigned job responsibilities (e.g., meeting coordination, advisor contracting, OST training, etc.)
- Support with tracking and reporting of Key Performance Indicators (KPIs) and metrics for quality oversight of applicable clinical operations related activities as assigned
- Collaborate/Interact with internal and external stakeholders as related to the conduct of required job responsibilities
- Took on additional responsibilities to improve overall team efficiency and effectiveness.
- Collaborated with cross-functional teams to streamline project workflows and enhance communication.
- Developed training materials for new employees to ensure smooth onboarding experiences.
- Facilitated meetings to gather stakeholder feedback and align project objectives effectively.
- Supported senior management in executing initiatives that drive operational efficiency.
- Maintained relationships with external partners to strengthen collaborative efforts on projects.
CLINICAL RESEARCH ASSOCIATE II
Avanir Pharmaceutical
Aliso Viejo
09.2020 - 12.2021
- Site management for multiple study sites on phase 3 global trials
- Serve as the primary contact for EDC, IRB, and participant tracking vendors
- Work and assist with study management and team in CRO and vendor oversight
- Assist with tracking study budget related to site and vendor financials on a monthly basis
- Work with Medical Science Liaisons and Field Monitor to address site issues such as unanswered queries, missing data, and low recruitment and enrollment efforts.
- Lead weekly vendor meetings with EDC vendor
- Lead and manage central IRB vendor
- Partake in site selection and feasibility process with study management
- Assist study management and team in the planning and coordination of investigator meetings and town halls
- Always maintain eTMF at an inspection ready status
- Ensure that study is executed in accordance with protocol
- Reviewed clinical trial documentation for accuracy and completeness.
- Coordinated communication between study sites and project teams.
- Reported to project manager for issues related to overall study status.
- Interacted with sponsors, CROs, investigators, vendors and subcontractors as needed.
- Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
CONTRACTOR- IN-HOUSE CRA I
Advanced Clinical
Aliso Viejo
09.2020 - 02.2021
- Adhered to all relevant regulations including ICH, PhRMA and CFR guidelines, policies, SOPs, and procedures.
- Prepared, collected, and tracked master study-level and site documents to ensure compliance and readiness for study initiation.
- Responsible for collecting essential documents from sites and ensuring sites are trained in collaboration with the site monitor.
- Supported the Clinical Study Manager and Director of Clinical Study Management in conducting study feasibility and site selection processes.
- Responsible for site budget development and negotiations if needed.
- Developed informed consent forms and study-specific documents to facilitate regulatory approval and enhance participant understanding.
- Responsible for planning and participating in investigator meetings.
- Updated CTMS under guidance of Clinical Study Manager.
- Executed database lock activities to finalize data for analysis.
- Responsible for ensuring all documents are filed and reviewed in the TMF.
- Responsible for ensuring all site close-out activities are completed.
- Managed project timelines and deliverables for clinical research initiatives.
- Collaborated with cross-functional teams to streamline operational processes.
- Coordinated communication among stakeholders and project teams to ensure alignment and timely project updates.
IN-HOUSE CRA
Tanvex BioPharma USA, INC.
Irvine
01.2020 - 05.2020
- Manage clinical studies/sites to assure accurate and timely initiation, enrollment, conduct, and completion of the assigned trial.
- Correspond with Investigators, CRAs, and CROs
- Contribute to study development, conduct, and closure.
- Contribute to key study documents, such as the protocol, informed consent form, monitoring plans, and case report forms.
- Ensure all essential documents are properly reviewed and approved, prior to filing within the Trial Master File
- Collaborate with the monitoring team for visit and protocol compliance.
- Manage adherence to study contracts and payment requirements.
- Support FDA submissions with Regulatory Affairs
- Contributed innovative ideas and solutions to enhance team performance and outcomes.
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
- Prioritized and organized tasks to efficiently accomplish service goals.
- Collaborated closely with team members to achieve project objectives and meet deadlines.
- Worked with cross-functional teams to achieve goals.
- Recognized by management for providing exceptional customer service.
- Utilized various software and tools to streamline processes and optimize performance.
- Demonstrated strong problem-solving skills, resolving issues efficiently and effectively.
CONTRACTOR- SITE START-UP ASSOCIATE I
Lancesoft (Allergan, Inc.)
Irvine
05.2019 - 01.2020
- Lead study start-up representative for multiple studies (IND and IDE) with competing timelines for FPFV
- Lead discussion with Operational Study Leads to ensure timely preparation of study start-up materials and templates prior to site deployment.
- Identify clinical team needs, contracting and managing vendor supported tasks and tracking critical timelines.
- Oversee Site Start-Up projects as liaison for IRB, IRB submission, and consent form review.
- Compiled and presented metrics to senior management to inform decision-making.
- Monitor project plans and communicate and troubleshoot the leading and lagging indicators to meet Site Initiation Readiness at the Investigator Meetings.
- Review and report on deliverables of vendors.
- Collection and review of essential documents (1572, financial disclosures, etc.)
- Maintain the tracking of project metrics in Site Start-Up tracker and provide status updates.
- Work with internal groups to meet deliverables (i.e., Patient Recruitment, Clinical Development, and Clinical Planning).
- Manage information sharing (i.e., Site Start-Up tracker, Site Identification Tracking Tools.)
- Developed standard operating procedures and working documents to effectively communicate unit processes.
- Actively share new ideas for efficient and seamless process improvement and implement process improvement for Site Start-Up initiatives.
- Provide agendas, meeting minutes and manage follow up items for all Site Start-Up meetings that are assigned.
- Maintain all aspects of Site Start-Up portal documentation by updating trackers and providing frequent study updates.
- Maintain electronic Clinical Study File (Trial Master File (TMF)).
- Ensure regulatory documents received from sites meet quality standards during study start-up phase as well as ongoing/maintenance phase.
- Reviewed ICF language and edits, escalating issues to relevant functional groups including Legal, Medical Safety, and Clinical Development.
- Executed daily responsibilities with precision and efficiency to support team operations.
- Contributed innovative ideas and solutions to enhance team performance and outcomes.
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
- Prioritized and organized tasks to efficiently accomplish service goals.
- Collaborated closely with team members to achieve project objectives and meet deadlines.
- Worked with cross-functional teams to achieve goals.
- Provided support and guidance to colleagues to maintain a collaborative work environment.
SENIOR CLINICAL PROJECT ASSISTANT
ClinDatrix, Inc.
Irvine
07.2018 - 03.2019
- Maintain electronic Clinical Study File (Trial Master File (TMF)).
- Generate and maintain study-specific electronic tracking tools for the following: regulatory documents, monitoring visit intervals and reports, screening and enrollment, protocol, deviations, serious adverse events (SAEs), and study supplies.
- Generate Protocol Summary of Change and send for approval.
- Ensure proper shipment and tracking of clinical supplies (e.g., case report forms, site regulatory binders, etc.) to the site.
- Review, track, and file screening and enrollment information from the clinical sites.
- Interface with Clinical Research Associates (CRAs) to address issues and resolve problems as directed by the Clinical Project Manager.
- Ensure that all study-related documents collected from or submitted by the clinical sites are filed in the Clinical Study File (Trial Master File (TMF)).
- Index and prepare Clinical Study File contents for return to the sponsor at the close of the clinical trial.
- Attend SOP training meetings and ensure that training records are updated.
- Review Clinical Research Associates (CRAs) expense reports.
- Review Interim Monitoring Visit reports and follow up letters.
- Assist Clinical Project Manager with any day-to-day study operational issues.
- Coordinated project schedules and timelines for clinical research studies.
- Assisted in preparing and maintaining regulatory documentation for compliance.
- Managed communications between cross-functional teams and stakeholders.
- Organized meetings, taking detailed minutes and tracking action items.
- Supported data entry and management within clinical trial management systems.
- Monitored project progress, identifying potential issues for resolution.
- Collaborated with team members to ensure adherence to study protocols.
- Assisted with monitoring activities such as source document verification, remote monitoring, data query resolution.
- Maintained detailed records of all aspects of clinical studies in accordance with Good Clinical Practices guidelines.
- Managed communication between sponsors, vendors, research sites and other stakeholders involved in the clinical trial process.
- Assisted with the preparation of clinical trial documents, including informed consent forms and case report forms.
SENIOR REGULATORY COORDINATOR - SUPERVISOR
Collaborative Neuroscience Network, LLC.
Garden Grove
03.2016 - 07.2018
- Responsible for assisting with the organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, reporting on the status of various research tasks such as initial IRB submissions, continuing review, advertising materials, IND safety reports, SAE reports, deviation/violation reports, amendments, and close-out of studies.
- Coordinate required investigator and study staff training, collect and maintain in-date regulatory documents and profiles of investigators.
- Develop relationships with sponsors, CROs, monitors, investigators and CNS Network Staff in a professional and educational manner.
- Assist in gathering pre-study documentation from investigators (i.e., CVs, questionnaires, etc.) and provide to sponsors in preparation for site selection visits.
- Maintain daily communication with coordinators and regular communication with sponsors and the IRB on an as needed basis.
- Follow up with monitors post visit on outstanding issues.
- Responsible for training new regulatory staff members.
- Develop in-house regulatory documents.
- Coordinate study start-up.
- Coordinated regulatory submissions for clinical trials and product approvals.
- Managed documentation for compliance with federal and state regulations.
- Collaborated with cross-functional teams to ensure regulatory alignment.
- Developed training materials on regulatory processes and requirements.
- Reviewed and updated standard operating procedures for compliance accuracy.
- Assisted in audits by preparing necessary regulatory documentation and reports.
- Maintained comprehensive records of all regulatory interactions and correspondence.
- Prepared documents for submission to relevant authorities as needed.
- Communicated regularly with external stakeholders regarding status updates on submissions.
- Tracked progress of submissions throughout their life cycle.
- Assisted in the preparation of responses to questions from regulators or customers.
- Advised management on potential risks associated with non-compliance issues.
- Submitted applications and amendments to regulatory agencies.
REGULATORY COORDINATOR
Childrens’ Hospital Orange County (CHOC)
Orange
01.2011 - 03.2016
- Responsible for ensuring compliance of the clinical research enterprise with all related regulatory policies and guidelines including federal, state, local, as well as the policies and procedures outlined by Children’s Hospital of Orange County (CHOC).
- Design, develop, implement, and monitor the research compliance program coordinating institutional-wide initiatives to prevent, detect and respond appropriately to compliance risks.
- Assess the research compliance needs of the institution and its network and affiliates to recommend tools and approaches necessary to promote and enforce compliance in clinical research.
- Responsible for developing a culture of regulatory compliance through training, education, strategic planning, study monitoring, and collaborations within CHOC and its affiliates.
- Receive and evaluate allegations of research misconduct and manage any further inquiry and investigation into these allegations as the specific case requires.
- This will ensure compliance with PHS regulations for the handling and reporting of research misconduct.
- To provide guidance, information and education to researchers, staff, students and administrators regarding the interpretation and implementation of the regulatory requirements related to research misconduct.
ASSISTANT ONCOLOGY RESEARCH COORDINATOR
Childrens’ Hospital Orange County (CHOC)
Orange
02.2008 - 01.2011
- Provide assistance in preparing for study visits, filing, copying, data entry, query resolution, inventory of lab supplies and assist in the management of patient flow during the clinic.
- Participated in weekly research meetings, discussing various ongoing research projects.
MEDICAL ASSISTANT
Talen Orthopedic
Westminster
12.2006 - 09.2007
- Back office and front office. Blood draw and vital signs for patients
- Pulled and prepared patient charts for appointments, ensuring timely access to necessary information.
- Verified patient insurance details to confirm coverage prior to appointments, facilitating smooth patient flow.
Education
Master of Arts - Administration
Concordia University
Irvine, CA01-2020
Bachelor of Science - Health Administration
University of Phoenix
Ontario, CA01-2011
Medical Assistant -
Concorde Career College
Garden Grove, CA01-2006
Skills
- Clinical trial management
- Regulatory compliance
- Data management
- Document control
- Project coordination
- Vendor management
- Stakeholder engagement
- Cross-functional collaboration
- Meeting facilitation
- Time management
- Work prioritization
- Task prioritization
- Problem solving
- Client engagement
- Team collaboration
- Cross-functional teamwork
- Effective communication
- Written communication
- Problem-solving
Clinical Research Studies
- Allergan - BOTOX in the Treatment of Urinary Incontinence Due to Overactive Bladder
- Allergan - Evaluation of Safety and Efficacy of XXX-XXXXX after Single Intramuscular Treatment in Participants with Glabellar Lines
- Allergan- A multicenter, single-blind, randomized, controlled study of the safety and effectiveness of XXXXXXXXX injectable gel for correction of infraorbital hollowing
- Allergan - A Double-blind, Placebo- and Active-Controlled Evaluation of the Safety and Efficacy of XXXXXXXXX in Pediatric Patients 7-17 Years with Major Depressive Disorder
- Allergan- A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of XXXXXXXX in Patients with Diabetic Gastroparesis
- Allergan- A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of XXXXXXXXX in Participants with Moderately to Severely Active Ulcerative Colitis
- Children’s Oncology Group- Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
- Children’s Oncology Group- Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
- Children’s Oncology Group- Chemoimmunotherapy With XXXXXXXXX in Relapsed Acute Lymphoblastic Leukemia (ALL)
- Children’s Oncology Group- Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia
- Defender Pharmaceuticals, Inc. - A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of XXX-XXX Nasal Gel on Ocean Going Vessels for the Prevention and Treatment of Nausea Associated with Motion Sickness
- Otsuka Pharmaceutical Development & Commercialization, Inc. - A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of XXXXXXXXXX in the Treatment of Subjects With Bipolar I Disorder
- Sunovion- A 4-Week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexibly-dosed, Multicenter Study to Evaluate the Efficacy and Safety of XXX-XXXXX in Acutely Psychotic Adult Subjects With Schizophrenia
Timeline
SENIOR CLINICAL OPERATION ASSOCIATE
Otsuka
01.2022 - Current
CLINICAL RESEARCH ASSOCIATE II
Avanir Pharmaceutical
09.2020 - 12.2021
CONTRACTOR- IN-HOUSE CRA I
Advanced Clinical
09.2020 - 02.2021
IN-HOUSE CRA
Tanvex BioPharma USA, INC.
01.2020 - 05.2020
CONTRACTOR- SITE START-UP ASSOCIATE I
Lancesoft (Allergan, Inc.)
05.2019 - 01.2020
SENIOR CLINICAL PROJECT ASSISTANT
ClinDatrix, Inc.
07.2018 - 03.2019
SENIOR REGULATORY COORDINATOR - SUPERVISOR
Collaborative Neuroscience Network, LLC.
03.2016 - 07.2018
REGULATORY COORDINATOR
Childrens’ Hospital Orange County (CHOC)
01.2011 - 03.2016
ASSISTANT ONCOLOGY RESEARCH COORDINATOR
Childrens’ Hospital Orange County (CHOC)
02.2008 - 01.2011
MEDICAL ASSISTANT
Talen Orthopedic
12.2006 - 09.2007
Master of Arts - Administration
Concordia University
Bachelor of Science - Health Administration
University of Phoenix
Medical Assistant -
Concorde Career College