- Responsible for IQVIA Core team with various Sponsors- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.- Provide monitoring visits and site management for a variety of protocols, sites- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.- May provide assistance to less experienced clinical staff.

Primarily responsible for Phase II/III clinical studies in the therapeutic areas of HIV-associated infections and immunosuppression, including tuberculosis, and hepatitis B, and CVD with strict adherence to ICH/FDA regulations.• Primarily responsible for all regulatory matters concerning study protocols.• Preparing the protocol specific submission packages (i.e. first submissions, amendments, SAE’s, deviations/violations, andsafety reports to the IRB/IEC).• Ensure that the documentation submitted by Investigators for IRB/EC review is completed and within the specified timeline.• Respond to IRB queries and tracking of approval and acknowledgement letters; preparing related study documents (i.e.investigator binders and trial master files).• Update information (i.e., investigator file binders, regulatory binders, investigator meeting binders, training manuals, andpharmacy manuals) for the study team.• Develop regulatory review history logs to track all IRB/IEC submissions and approvals for each clinical study; Reminding the PIand study team regarding the timeline for annual reports, progress reports, and continuing reviews.• Educate and train site and study staff in conduct and management of sponsored studies, including assurance to regulatoryand ICH/ GCP compliance.• Appropriately resolve issues related to trial monitoring and management.• Assist senior CRAs on the research activities.

- Act as the Client's main contact as well as primary liaison role in all matters regarding central laboratory services, following up and responding to study specific inquiries from Sponsors, Physicians, all internal Laboratory Departments, and third parties - Perform maintenance and troubleshooting for scientific instruments, methods and procedures- Keep up-to-date with scientific and medical knowledge in the areas of interest- Plan study project schedule and procedures to meet the requirements of client- Working with clients to review progress, adjust development and report the results accordingly

- Planning for each product development and process to achieve the goal including test method development, method and product validation, and stability testing- Research consumer behavior, market trends including raw materials to develop product to meet consumer satisfaction - Cooperate with management planing, customer service, purchasing and other related departments- Seeking for new clients and suppliers to expand the market- Work closely with suppliers and clients to resolve development issues, as well as conducting supplier trade studies, evaluations, and second source efforts.

- Did my undergraduate thesis and then continued researching the effect of Melatonin on neural differentiation of human pluripotent stem cells (for neurodegenerative diseases)- Research assistance by preparing chemicals and reagents and performing molecular techniques such as qRT-PCR, PCR, flow cytometry, cell culture, RNA extraction, Western blot, etc.- Aided students and professors in performing the experiments (such as demonstrations)