謝艾芸
Clinical Research Associate
The knowledgeable clinical research assistant is adept at recognizing clinical values and abstract data from source documents. Uses analytical skills to identify data or patient safety issues. A versatile clinical research professional is knowledgeable about coordinating patient information, laboratory samples, and compliance documents for diverse clinical
trials. Highly organized and thorough with good planning and problem-solving abilities. Certified in Taiwan. Skilled at collecting specimens, dispensing medications, and consulting with patients during the course of clinical research trials. Experienced in coordinating schedules, results, and documentation. Focused Clinical Research Coordinator well-versed in study protocols, standard operating procedures, and general trial oversight. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring 2.2 years of related experience to a challenging new role.
CONMED PHARMACEUTICAL & BIO-MEDICAL CORPORATION.
Mackay Medical College
Taipei, Taiwan
Skills
Languages
English
・
Fluent
Chinese
・
Native or Bilingual
Work experiences
Clinical Research Associate
CONMED PHARMACEUTICAL & BIO-MEDICAL CORPORATION.
Jan 2021 ~ Present
Coordinated clinical trials focused on disorders such as uremic pruritus.
Manage the clinical trials：
– Integrative clinical trials in 9 sites to approve IRB, and responsible for team education training.
– Develop protocols, case reports, statistical analysis plans, and standard operating procedures to comply with the ICH/GCP.
-Corporate with SMO company to recruit and manage study nurses.
- Management of projects to ensure the adherence of the project to quality standards and the approved timeline and budget.
Clinical Research Associate
Taiwan Bio Therapeutics
Feb 2019 ~ Oct 2020
・
1 yr 9 mosCoordinated clinical trials focused on disorders such
as CLI and OA.
Worked with principal investigator and sponsors to
facilitate daily trial activities and comply with
research protocols.
Followed informed consent processes and
maintained records.
Maintained compliance with protocols covering
patient care and clinical trial operations.
Participated in initiation visits and investigator
meetings, implementing trials in accordance with
study timelines and budgets.
Research Assistant
Hospital, Taipei city, Taipei city
Mar 2016 ~ Oct 2018
・
2 yrs 8 mosCoordinated clinical trials focused on disorders such as migraine, dementia, and AI software development.
Analyzed statistical data using both modern and traditional methods.
Summarized search results by preparing written reports, graphs, fact sheets, and tables.
Performed statistical, qualitative, and quantitative analysis.
Collaborated with the leadership team to identify relevant questions and determine the best methods of collection.
Planned, modified, and executed research
techniques, procedures, and tests.
Conducted DNA, RNA, and protein extraction and
quantification using spectrophotometer and gel
electrophoresis.
Submitting IRB, explaining ICF to patients and visiting
patients.
Educations
Mackay Medical College
Master of Science (MS)・Biomedical Science
2013 - 2015
Chung Shan Medical University
Bachelor of Science (BS)・Biomedical science
2007 - 2011
