Cindy Zhang
Kellyville,NSW
Summary
Detail-oriented and competent Clinical Research Associate with experience working with various protocols, managing different sites, and effectively working with both internal and external stakeholders. Knowledgeable about conducting monitoring visits at various stages of studies. Ready to apply my 18 months of CRA experience and 6 years of study coordinator expertise to a more challenge role.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
ICONPLC
04.2022 - Current
- Managed over 10 protocols, overseeing 7 different sites and ensuring strict adherence to study protocols.
- Conducted over 50 site monitoring visits including SIVs, IMVs and close out visits.
- Monitored and ensured compliance with protocols for Phase 2 and 3 clinical trials in Respiratory, Type 1 diabetes and some other rare disease.
- Provided support for some Phase 1 study team to review study documents.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy, completion and quality.
- Collaborated with site and sponsor to troubleshoot and provide solutions to study-related issues.
- Reviewed data queries and listings and worked with study sites to resolve data queries in a timely manner, maintaining a 100% query resolution rate through out the trial.
- Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
- Monitored safety of human subjects and oversaw consent procedures to comply with regulations.
- Conducted site training sessions on protocol requirements, resulting in a decrease in protocol deviations.
- Attended regular trainings, forums and meetings to upgrade skills and knowledge, with 100% compliance.
- Assisted other team members with monitoring visits, leave coverage.
- Involved in new CRA space streamline set up including review accuracy of documents, system creation and verification.
- Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
Clinical Trial Coordinator
Westmead Hospital
09.2016 - 03.2022
- Managed over 20 clinical trial studies, followed up over 10 studies from site set up to site close.
- Monitored unit budget to meet financial objectives for spend rate and funding
- Engaged in process of site set up including site selection, contract negotiation and regulation submission
- Maintained compliance with protocols covering patient care and clinical trial operations
- Coordinated clinical trials focused on disorders such as general CKD, ESRD, dialysis and kidney transplant
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies
- Actively involved in patient’s recruitment, achieved recruiting task for most of trial studies
- Gathered, processed and shipped lab specimens
- Followed informed consent processes and maintained records
- Collected data and followed research protocols, operations manuals and case report form requirements
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
- Report AEs, SAEs and SUSAR in timely manner
- Resolved problems, improved operations and provided exceptional care to trial patients
- Used critical thinking to break down problems, evaluate solutions and make decisions
- Created plans and communicated deadlines to ensure studies were completed on time.
Registered Nurse in Renal transplant unit
Westmead Hospital
03.2011 - 09.2016
- Provided direct patient care, stabilized patients and determined next course of action
- Advised patients and caregivers of proper wound management, discharge plan objectives, safe medication use and disease management
- Managed quality care for patients with diabetes, end-stage renal disease and kidney transplantation
- Evaluated healthcare needs, goals for treatment and available resources of each patient and connected to optimal providers and care
- Administered medications and treatment to patients and monitored responses while working with healthcare teams to adjust care plans
- Implemented medication and IV administration, catheter insertion and airway management
- Collaborated with physicians to quickly assess patients and deliver appropriate treatment while managing rapidly changing conditions
- Collected blood, tissue and other laboratory specimens and prepared for lab testing
- Educated patients, families and caregivers on diagnosis and prognosis, treatment options, disease process and management and lifestyle options
- Trained new nurses in proper techniques, care standards, operational procedures and safety protocols
- Audited charts and reviewed clinical documents to verify accuracy.
Registered Nurse
Prince of Wales Hospital
11.2009 - 03.2011
- Completed new graduates program, had experience on Neurology, Cardiology, Rehabilitation and HDU.
- Oversaw delivery of care for patients on medical-surgical unit, providing direct care, delegating nursing assignments and supervising team comprised of nurses, LPNs, technicians, and unit clerks.
- Provided exceptional care to high-acute patients needing complex care such as ventilator management, extensive wound care and rehabilitation
- Managed care from admission to discharge
- Administered medications via oral, IV and intramuscular injections and monitored responses
- Provided direct patient care, stabilized patients and determined next course of action
- Organized and managed care of patients undergoing various therapies and procedures
- Monitored patient condition by interpreting and tracking EKG readings, identifying irregular telemetry readings and updating team members on changes in stability or acuity.
Education
M.D., Health (research) - Health Research
Western Sydney University
Sydney, NSW08.2021
M.D., Occupational and Environmental Health -
Curtin University
Perth, WA06.2016
Bachelor of Science, Nursing -
Western Sydney University
Sydney, NSW11.2009
Skills
- Site Management
- Independent Site Monitoring
- SDV and SDR
- Informed Consent Process
- Patient Safety monitoring
- Study protocols Adherence
- Regulatory Compliance
- Good Clinical Practices
- Good Documentation Practices
- ISF and TMF reconciliations
- IP accountability check
- Software Proficiency(Word, Excel, Onenote, PPT)
- Analytical and Critical Thinking
- Problem-solving skills
Certification
GCP certificate
Languages
Chinese (Cantonese)
Professional Working
Chinese (Mandarin)
Native or Bilingual
Timeline
Clinical Research Associate
ICONPLC
04.2022 - Current
Clinical Trial Coordinator
Westmead Hospital
09.2016 - 03.2022
Registered Nurse in Renal transplant unit
Westmead Hospital
03.2011 - 09.2016
Registered Nurse
Prince of Wales Hospital
11.2009 - 03.2011
M.D., Health (research) - Health Research
Western Sydney University
M.D., Occupational and Environmental Health -
Curtin University
Bachelor of Science, Nursing -
Western Sydney University
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