Barbara Mccombie Email and Phone Number

Project Management of multiple studies. Prepare protocols, review data, and write reports.

For approximately 2.5 yrs, I served as Institute Animal Care and Use Committee ( IACUC) Coordinator and Compliance Manager. Managed records and correspondence to meet regulatory compliance; IACUC protocol approvals moved from 70 to 90% acceptance at initial submittals. Promoted to Study Coordinator where I assisted investigators by preparing IACUC and health and safety statements, study protocols, and final reports for preclinical toxicology and infectious disease studies. Scheduled… Show more For approximately 2.5 yrs, I served as Institute Animal Care and Use Committee ( IACUC) Coordinator and Compliance Manager. Managed records and correspondence to meet regulatory compliance; IACUC protocol approvals moved from 70 to 90% acceptance at initial submittals. Promoted to Study Coordinator where I assisted investigators by preparing IACUC and health and safety statements, study protocols, and final reports for preclinical toxicology and infectious disease studies. Scheduled, managed, and monitored studies to meet FDA requirements; Reviewed, analyzed and summarized data. Interfaced with technical staff, scientists, quality assurance and sponsors to ensure study requirements were met. Reduced repeat noncompliances by providing training and guidance to technical staff; Served as PRN quality assurance auditor; Facilitated scheduling and management of studies by interacting with investigators and preparing summary slides for weekly insitute-wide meeting; Show less

Conducted and managed research and GLP developmental and reproductive toxicology studies that resulted in co-authorship of 14 manuscripts, 22 abstracts, and 7 final reports. Conducted pharmacokinetic studies in pregnant rodents for PBPK modeling; Helped improve regulatory compliance by serving as a member of Quality Assurance Advisory and Institute Animal Care and Use Committees; Served as PRN quality assurance auditor;

Originally screened monoclonal antibodies by ELISA for ovarian cancer project; Promoted to product manager where I led GMP production of fertility diagnostic kit, shipped product, provided sales reports, maintained customer database and relations;

Conducted experiments in biochemistry, immunology and toxicology. Projects included 4 years of research related to inborn errors of metabolism, 7 years in complement, and 3 years in P-450 drug metabolism.