• Provided oversight of CRO responsible for case processing and submissions to ensure quality met ICH-GCP and company standards. • Transitioned pharmacovigilance (PV) activities of a Phase III trial from a CRO to an in-house PV team including migration of the safety database, case intake and processing, and safety reporting. • Responsible for all safety report submissions (Expedited Safety Reports, Periodic Line Listings, and Development Safety Update Reports) including coordination and oversight of submission vendors. • Assisted in the implementation and upgrade of Argus Safety Database, including user acceptance testing (UAT), creation of data entry conventions, and change controls to optimize the system. • Business lead for psiXchange (safety report distribution platform); assisted in the configuration, implementation, and post-launch optimization of psiXchange; developed user guide for clinical sites and training for Clinical Operations team; responsible for study site contact maintenance and distribution of safety reports. • Authored departmental standard operating procedures (SOPs) and work instructions. • Participated in audit of CRO and Health Authority Inspections. • Interviewed candidates to expand our team and trained new hires on departmental and company processes. • Perform case processing, SAE reconciliation, query management, and filing to the Trial Master File. • Managed safety activities of Clinical trials phase I-III from study startup to closeout.

•Prepare and distribute safety reports according to ICH GCP•Maintain open communication between clients and CRO•Submits expeditable safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with relevant legislation and the project-specific contractual agreement•Support the generation of Aggregated Safety Reports (e.g. EU Annual Safety Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks•Learned basics of coding to automate several time-consuming tasks.

•Conducted research directed at elucidating the role of mutations in Connexin 43 in Oculo-dento-digital-dysplasia•Supported several research projects by preparing samples and reagents, running assays, and maintaining cell lines to be used in experiments•Trained new lab members on equipment and techniques•Managed Lab Safety Programs, and worked to ensure all lab members complied with safety standards •Implemented systems and procedures to organize the laboratory•Responsible for purchasing all necessary equipment and reagents for the lab

Project: Biological screening for promising anti-inflammatory agents.•Extracted monocytes/macrophages from mice (resident peritoneal and bone marrow) on routine basis•Performed immunochemical assays (including ELISAs and Western Blots) to determine anti-inflammatory potential of purified compounds•Investigated the mechanism of action of select compounds via Western blot

Development of tools to assess the effects of Lunasin on normal development and tumor progression in Drosophila melanogaster.•Cloned lunasin gene into a Drosophila specific plasmid vector, pUAST•Created transgenic Drosophila capable of overexpressing Lunasin and Lunasin tagged with a fluorescent marker, EGFP•Observed and recorded developmental phenotypes due to expression of Lunasin•Generated tools for use in tumor progression studies

Cellular and Molecular Biology Lab (Bio 322)•Taught two sections of the Cellular and Molecular Biology lab each semester•Prepared materials for each lab period (i.e. buffers, media plates, media, stock solutions, etc.)•Updated course materials to match the objectives of the class

•Trapped mosquitoes using CDC Light and CDC Gravid traps•Retrieved trapped insects and reset traps daily•Used dissecting microscope and key to identify collected mosquitoes to genus (and species when possible)•Collected data to be used for a larger project on West Nile Virus transmission and prevalence