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UTMB Health seeks a Research Scientist I in Ophthalmology to oversee regulated nonclinical studies under GLP guidance. The role entails acting as Study Director, coordinating scientific, technical and regulatory aspects, and ensuring compliant interpretation and reporting of results.
You will design studies, manage data analyses, and potentially contribute as PI on extramural programs, presenting findings in manuscripts and collaborating with fellows and staff across the ORNcS and sponsors.
Galveston, Texas, United States
Research Academic & Clinical
UTMB Health
Requisition # 2500940
Ph.D. and/or MD, DVM. 1 - 3 years of experience conducting regulated studies. 7+ years of experience in infectious diseases research with viral or bacterial pathogens, including animal studies. Good Laboratory Practice training. BSL3 and/or BSL4 laboratory training. Experience with qualitative data collection and analysis including mixed method approaches. Able to obtain clearance for work with Tier 1 Select Agents and be registered as a Principal Investigator under the US Federal Select Agent Program (FSAP).
Function : The Regulatory Scientist II will be assigned as a Study Director, as defined by the U.S. FDA Good Laboratory Practice (GLP) regulations (21CFR58), and will serve as the single point of study control with overall responsibility for the scientific, technical and regulatory conduct of studies as well as for the interpretation, documentation and reporting of results. The Regulatory Scientist II works in conjunction with the Scientific Director for the Institutional Office of Regulated Nonclinical Studies (ORNcS), study sponsors and/or funding agencies to design and execute regulated nonclinical studies compliant with the U.S. FDA GLP regulations or under quality systems that utilize the US FDA GLP regulations as a reference standard. The Regulatory Scientist II may also function as a Principal Investigator for extramurally funded research programs and be expected to manage complex programs with multiple studies.
Commensurate with experience
Compensation