IVD clinical trial for Alinity m platform. • Monitoring studies with complex designs (multiple sites, instruments, assay)• Perform SIV, verification of study staff qualification, site training, IMV, and Closout visits at study sites • Ensures the study is conducted and documented properly by carrying out the following activities: the main line of communication, verification of the accuracy of source documents and study records, IRB reports• Verification of proper maintenance/storage of investigational material and/or specimen accountability, determine adverse events/protocol deviation• Actively participate as a member of the cross-functional project team• Assessing data generated by clinical sites• Prepare clinical protocol, clinical brochure, case report forms, informed consent, and other required documents and presentations for clinical studies• Monitoring studies with complex designs (multiple sites, instruments, assay)• Perform SIV, verification of study staff qualification, site training, IMV, and Closout visits at study sites • Ensures the study is conducted and documented properly by carrying out the following activities: the main line of communication, verification of the accuracy of source documents and study records, IRB reports• Verification of proper maintenance/storage of investigational material and/or specimen accountability, determine adverse events/protocol deviation• Actively participate as a member of the cross-functional project team• Assessing data generated by clinical sites• Prepare clinical protocol, clinical brochure, case report forms, informed consent, and other required documents and presentations for clinical studies

• Conducted verification, and validation studies of assays for infectious diseases on the Alinity m platform (HIV, HBV, CMV, Covid-19)• Performed product validation support studies• Reports and regulatory submissions

• Conducted clinical studies, monitored diagnostics/clinical trials, and clinical technology experience (Electronic Data Capture – Medrio, ClinTrack)• Monitored and managed Phase III clinical studies to assess the effectiveness of the new antimicrobial drug (Rempex), managed diagnostics trials (Cepheid, Roche, BD, and Qiagen)• Served as primary contact for various collaborations (University of Chicago, Wayne University and Cepheid, Nanosphere, Inc., Roche, BD) and contract research organizations (CROs)• Involved in specimen shipping activities• Communicated with sales representatives, clinicians, scientists• Prepared study memos for physicians, education materials for patients• Prepared in-depth, timely, and transparent study protocols, ensure protocol adherence according to Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), processed CRFs• Prepared reports and compliance-mandated informed consent forms• Screened and recruited patients for trials• Contributed to weekly meetings to discuss disparate possibilities with a cross-functional team that included physicians, nurses, directors of clinical laboratory, and an Infection control team• Internal trained for GLP, GCP, HIPAA, and PHI• Developed in-house in vitro diagnostics (IVD) assays to detect bacterial pathogens/antibiotic resistance

Conducted research in the area of Amyotrophic Lateral Sclerosis (ALS) and Parkinson's diseases to identify possible primary genetic causes or risk factors. Demonstrated an association of variants in the Paraoxonase gene cluster with sporadic ALS. - Research in the area of Amyotrophic Lateral Sclerosis (ALS) and Parkinson diseases to identify possible primary genetic cause or risk factors: association study (SNP genotyping, sequencing, PCR); bioinformatics (PLINK, Haploview, Kaplan-Meier and Cox hazard-proportional regression analyses, HapMap) - Investigation of mechanism of Friedreich’s ataxia (DNA/RNA tissue extraction, RT-PCR, gene expression, Western blot, cell culture, confocal imaging).