Nichamon Pingkul

-With over six years of experience in clinical research of university medical center focus on phase I and phase III.

-I have in-depth knowledge on clinical trial operation, regulatory standards, medical terminology, scientific complexity, cancer biology and type, pathology, infectious disease and vaccine.

-With positive can-do attitude, self-starter, proactive and works well under pressure

-Master of Science Program in Public Health Infectious Diseases and Epidemiology (Microbiology,Virology) at Mahidol University.

-Bachelor of Science program in Anatomical Pathology.

My responsibility are

• Assist in protocols development (objective, study design, methodology, statistics), consent form, CRF and literature review in clinical trial phase I
• Preparation for IRB/ IEC submissions
• Ensure compliance with each study’s protocol and all necessary document, investigator product, material are available
• Led the coordination of clinical trials with study team, trial participants and regulatory bodies
• Participants recruitment and selection by interview and medical record to determine compliance with inclusion and exclusion criteria
• Informed consent procedures and participants maintained of the right, safety and well-being in the trials
• Perform medical test including vital sign, laboratory value, ultrasound image and other imaging studies
• Provides trial participants education and medical information to ensure understanding of proper medication dosage, administration and disease treatment
• Manage investigator products, including storage, dispensing, and inventory control
• Managed day-to-day of clinical trial operations in phase I and phase III based on good clinical practice (GCP) and regulatory compliance
• Collaborates internal research team and external parties in phase III
• Coordinate with the ethics committee, which safeguards the rights, safety, and well-being of all trial subjects and safety report
• Day-to-day self-monitoring activities based on protocol, SOPs, GCP standards
• Prepare for external monitoring visit, audits and inspection
• Specimen collection and handing of internal and external transportation
• Ensure and accurately of source data verification (SDV) , source data review (SDR) and collecting CRFs is complete
• Data collection and data analysis program
• Interpret result and discuss with a statistician, and investigator
• Prepare final report and manuscripts for publication

Master of Science Program in Public Health Infectious Disease and Epidemiology /Faculty of Public Health, Mahidol University ,2021-2023

• Understanding: research methodology, study design, infectious disease, epidemiology,

immunology, characteristics of pathogens and laboratory for diagnosis

• Focuses on: surveillance, prevention and control of infectious disease, the emergence of new threats and the development of treatments such as antibiotics and vaccines
• Techniques:
• Virus detection: TEM, virus isolation in cell culture, neutralizing antibody detection assay (PRNT, FRNT, LRNT)
• Bacteria detection: bacteria isolation, biochemical test, drug susceptibility test
• Parasite detection: cell culture techniques for parasite
• Immunological methods : ELISA, Immunochromatographic (IC) test, Flow cytometry
• Molecular methods: PCR, RT-PCR, DNA sequencing and molecular typing
• Developed research objective and proposal
• My thesis about “Seroprevalence of neutralizing antibodies from healthy adult sera in dengue-endemic areas against three genetic variants of DENV2 by luciferase reduction neutralization test (LRNT)”
• Using new research techniques and method
• Laboratory with neutralization technique
• LRNT is developed from neutralization test or plaque reduction neutralization test (PRNT), PRNT is considered the "gold standard" for detecting and measuring antibodies that can neutralize the viruses that cause many diseases
• LRNT is a neutralizing test and one of the most reliable serological assays

6

• Three DENV2 reporters displaying genetic variations of viral surface prM and E proteins from three DENV2 strains, representing the Asian I, Cosmopolitan and Sylvatic genotypes were used as the antigens in LRNT
• Analysis and Interpretation the result
• The results obtained from this study should provide new insight into the baseline sero-epidemiological data of dengue neutralizing antibodies among the population in the dengue-endemic region and further DENV vaccine implementation

Bachelor of Science Program in Anatomical Pathology / Faculty of Allied Health Sciences,

Burapha University, 2013-2017

• Deeply on: the causes, development, and effects of disease at the cellular and tissue level
• Understanding: examines tissue samples to diagnose diseases such as cancer, infections,

autoimmune disorders, and congenital abnormalities

• Focuses on Histopathology, Cytopathology, Surgical Pathology, Autopsy Pathology
• Techniques:
• Microscopy: use light and electron microscopes to study cells and tissue
• Immunohistochemistry: use antibodies to detect specific protein in tissue
• Molecular Techniques: PCR, FISH, and sequencing to study DNA and RNA