Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

Ya Xiao

Lidcombe,NSW

Summary

Analytical Clinical Research Associate with talents in project development and screening to document and report clinical study progress. Coordinates and facilitate site research activities and submits protocols for regulatory approval. Serves as point-of-contact for clinical research professionals and coordinates lab samples to compile detailed data.

Overview

10
10
years of professional experience

Work History

Clinical Research Associate

Ascentage Pharma
10.2022 - Current
  • Managed multiple oncology and haematology clinical trial studies at different sites across Australia including Westmead hospital (Sydney), Flinders Hospital (Adelaide), Frankston Private Hospital (Melbourne) and Princess Alexandra Hospital (Brisbane).
  • Conducted pre-study site visits, close out visit, remote and on-site monitoring for ongoing clinical trials for adherence to protocol, GCP, and local HREC/RGO regulatory.
  • Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues. Communicated effectively with staff members, physicians, and patients, employing active listening and interpersonal skills.
  • Oversee trials specimens collection, sample storage and shipment to vendors for data analysis.
  • Managed study drug inventory, coordinated study drug shipments and ensured proper storage and handling.
  • Implemented electronic data capturing systems to adhere with clinical research guidelines.
  • Collaborated with clinical study sites and vendors to troubleshoot and provide solutions to study-related issues.
  • Written and Submitted routine monitor reports and follow-up letters to facilitate internal and external communication.
  • Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
  • Liaised with finance department, CMC department, logistic department, personnel to communicate important clinical data and events.
  • Created work schedules for site staff and oversaw functioning of billing department.
  • Delivered effective onboarding and training to new and existing site staff members including principal investigators, sub-investigators, nurses, clinical trials coordinators, pharmacists on protocol requirements and study procedures to maximize coverage.
  • Identified opportunities to improve trial practices and implemented plans to decrease protocol deviations and enhance operational procedures.
  • Handled job duties for staff members which were unavailable or out of office.
  • Identified nurses' and staff training needs and devised training programs to close gaps.
  • Implemented new policies and educated staff on changes.
  • Delegated tasks to staff members, monitored completion of all duties and provided support to enhance performance.
  • Reviewed financial resources and prepared reports showing resource allocations.

Clinical Operation Coordinator

Clinical Development Ascentage Pharma
12.2021 - 09.2022
  • Liaised with cross-functional project team to support management of clinical projects e.g. finance team, CMC team, QA team, Data management team.
  • Liaised with vendors as needed e.g Global Logistic for IP distributor and storage including World Courier, PCI, Almac and TNT; Central labs, IP distributor
  • Support AUS team in planning and execution of clinical trials in accordance with ICH-GCP guidelines and local RGO/HERC regulations
  • Coordinated study site initiation, monitoring, and close-out visits for projects.
  • Maintained study timelines, budgets, and resources.
  • Communicated with study teams and site personnel to ensure study progress and resolve issues.
  • Developed and maintained study-related documents and materials.
  • Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Demonstrated strong organizational and time management skills while managing multiple projects.
  • Used critical thinking to break down problems during day to day operation, evaluate solutions and make decisions.
  • Implementation of new CTMS system, project tracking, maintenance of eTMF

Research Assistant

Garvan Institute of Medical Research
05.2017 - 11.2021
  • Managed and oversee pre-clinical studies in the field of breast cancer, prostate cancer and bone metastasis cancer, osteoporosis for internal researchers and PhD students, external collaborators including universities, research institutes and external drug companies.
  • Developed and managed animal model and colonies, study model,animal surgeries/techniques optimization and development.
  • Managed study related animal ethics activities for bone biology division including application writing, attending Animal Ethics Committee meetings, amendments and annual/ final reports writing and submission to ethic committee.
  • Manage lab operations, facilitate training sessions and supervise lab students.
  • Managed lab orders and lab supply budget control.
  • Designed, executed, and analysed clinical research studies for multiple study teams under bone division
  • Managed and maintained study databases and sample inventory.
  • Conducted literature reviews and writing study protocols and manuscripts.
  • Presented research findings in meetings and conferences
  • Trained and supervised junior staff and PhD candidates in laboratory protocols, study design and implement.

Animal Technician

University of Sydney
03.2016 - 04.2017
  • Provided technical services for researchers and students at uni animal facility including injections, gavage, alveolar and liver lavage, tissue sample harvest, bleeding, urine collection.
  • Performed colony management services to clients including internal researchers and external industry biotech companies.
  • Performed on boarding training to researchers including animal handling, animal facility online system, surgical procedures in PC2 lab and other trainings as requested.

Medical Device Assessor

Tianjin Medical Apparatus and Instruments Quality Supervision, Inspection Centre
06.2013 - 06.2015
  • One of eight centres affiliated with China Food and Drug Administration, speciality in implantable medical devices and in vitro diagnostic medical devices
  • For example, ELISA Diagnostic kit for Hepatitis B, HCG pregnancy test kit, heart stents, bone cement and contact lenses
  • Conducted Good Manufacturing Practice inspection at therapeutic goods manufacturers to ensure local and international manufactures meet specified standards and provide laboratory services. Including syringes and needles manufacturers, orthopaedic implant manufacturers, IVDs
  • Conducted regulatory and technical assessment of applications for medical devices (non-IVD and IVD devices) and other therapeutic goods, including evaluation of technical documentation and data, collating expert advices relevant to assessment, preparing a clear statement of reasons based on the investigation findings and knowledge of the regulations, and exercising delegation where appropriate.
    • Undertook evaluations and providing advice on engineering/biocompatibility aspects of medical devices in relation to the relevant ISO/GB standard of quality, safety and performance
  • Provided detailed technical bioengineering/biocompatibility expertise in the area of cytotoxicity, hemocompatibility, irritation, sensitization, implantation, and sub-chronic and chronic toxicity testing including anticipating problems and contributing to issues management.
  • Expertise in ISO13485 Quality management systems and GB/T 26124-2011 standard.
  • Coordinated and managed multi-component applications requiring liaison with internal and external professionals.
  • Implemented risk management approach to support regulatory decisions
  • Provided timely, quality and accurate advice on issues relating to medical device regulation and interpretation of legislation and guidelines in a particular area of expertise and knowledge
    • Managed record keeping in accordance with regulatory requirements and whole-of-government policy and standards.
    • Provided inputs and advice to policy development and business improvement related to medical devices when required and where appropriate.

Education

Master of Science - Animal Nutrition

University of Sydney
Sydney, NSW
04.2017

Master of Clinical Veterinary Medicine - Clinical Veterinary Diagnostics

Huazhong Agricultural University
Wuhan. China
06.2013

Bachelor of Veterinary Medicine -

Southwest University,
Chongqing City, China
06.2010

Skills

  • Proficient in Microsoft office including Word, Excel, Outlook, OneNote, Powerpoint
  • Time management and project management
  • Communication and Collaboration
  • Strong Problem-Solving Abilities
  • Multitasking and Organization
  • Interpersonal skills
  • Attention to detail
  • Flexibility

Accomplishments

  • Certificate Foundation of Project management Certificate (coursera)
  • Registered veterinary professional since 2013 (China)
  • ARCS Member; attended ARCS conference 2022
  • Attended and presented at the Australia and New Zealand Bone and Mineral Research (ANZBMS) International conferences (2020)
  • Plenary Poster: Can circulating Wnt antagonist Dkk1 alter bone mass by endocrine signaling
  • Garvan Award 2018 (Garvan Institute of Medical Research)

Timeline

Clinical Research Associate

Ascentage Pharma
10.2022 - Current

Clinical Operation Coordinator

Clinical Development Ascentage Pharma
12.2021 - 09.2022

Research Assistant

Garvan Institute of Medical Research
05.2017 - 11.2021

Animal Technician

University of Sydney
03.2016 - 04.2017

Medical Device Assessor

Tianjin Medical Apparatus and Instruments Quality Supervision, Inspection Centre
06.2013 - 06.2015

Master of Science - Animal Nutrition

University of Sydney

Master of Clinical Veterinary Medicine - Clinical Veterinary Diagnostics

Huazhong Agricultural University

Bachelor of Veterinary Medicine -

Southwest University,

Similar Profiles

CREATE PROFILE
Ya Xiao