Certified Clinical research, IRB and Regulatory affairs professional, who is excited to support total life-cycle management of US FDA regulated therapeutic products: biologics, cell and gene therapies, drugs, and medical devicesSpecialized Skills: Regulatory Affairs: US FDA and DHHS regulations, ICH and ISO guidelines, Quality management system, risk-management approaches, exposure to EMA and Health Canada regulationsClinical Research: Start-up, Conduct, and Close-out of clinical trials, IRB submission expertise, eTMF, CTMS, and EDC administrator, generation of regulatory documents and study binders, maintain Investigational drug supply chain, and facilitate Investigator/site meetings and training sessions, utilization of quality metrics to maintain regulatory standardsIRB Board: IRB chair since Aug. 2020Communication skills: Experienced technical/scientific writer and presented data at international conferencesDrug Discovery: Conducted preclinical oncology drug discovery research Project Management: Effectively collaborated with academic investigators, pharmaceutical and biotechnology industry partners, CROs, and diverse stakeholders