Clinical Scientist with 13 years of clinical trial experience in academia. Strong background in CNS, adaptable to specialized fields in medicine in general. Provided oversight and management of multiple observational studies and 2 phase III-like behavioral intervention clinical trials (see a list of projects in page 3). Lead author of academic manuscripts, IRB documents, informed consent forms, and study reports for regulatory authorities. 70 peer-reviewed publications. Advance proficiency in R (coding language), with in-depth understanding clinical data.
• Provided oversight and management of 3 clinical studies, including 1 behavior intervention clinical trial in mild cognitive impairment.
• Working closely with two Medical Directors and two Clinical Scientist on safety monitoring, study document preparation, and trial operations
• Reviewing incoming data, listings, and deviations weekly in coordination with Medical Directors
• Meeting with Medical Directors 2-3 times per week to ensure comprehensive adverse event review for multiple studies
• Participated in protocol development process by providing input on design elements such as inclusion and exclusion criteria, endpoints, sample size calculations.
• Produced study protocol amendments, informed consent forms, IRB submission documents, responded to IRB and KOL queries, and prepared study case reports for regulatory bodies
• Coordinated communication between investigative sites and sponsors regarding protocol amendments or deviations from standard operating procedures. Ensured GCP and ICH compliance for clinical studies.
• Lead author for manuscript writing for academic journals, published 10 papers in 2023
• Proficient with statistical analysis on comprehensive clinical data with 6 years of experience on R programming and 10 years with SPSS.
• Completed 2 clinical studies and 1 clinical trial.
• Performed patient evaluation, includes EHR review, physical exam, lab results, medical imaging diagnosis, biomarkers, and performing informed consent.
• Evaluated information and analyzed data to draw conclusions and present findings to scientific community and public.
• Assisted in the preparation of regulatory documents including informed consent forms.
• Analyzed large datasets using statistical software packages such as R or SPSS; provided summary statistics or graphical representations as requested.
• Maintained up-to-date knowledge of current Good Clinical Practices guidelines and FDA regulations governing clinical trials.
• Mentored postdoctoral fellows, graduate students, and clinical research assistants in biostatistics and medical writing
• Lead manuscript writing and data presentation at conferences.
• Gained expertise collecting and recording clinical study data, and performing informed consent and DSMIV diagnostic interview.
• Completed 1 clinical study in ketamine use disorder and 1 in post-stroke mental health status.
• Analyzed clinician and patient-reported outcome data with SPSS.
• Outreached for study recruitment.
• Drafted study report and manuscripts, presented study findings at conferences.