Study Coordinator- Role of oxidant susceptibility genes In severity of neonatal diseases associated with hyperoxic injury (Argentina Study)

Social And Scientific Systems, Inc., Silver Spring MD

Investigators

Abstract

The purpose of this work assignment is to provide a research coordinator for the study being conducted in Argentina titled, Role of oxidant susceptibility genes in severity of neonatal diseases associated with hyperoxic injury. The coordinator will oversee conduct of the study, IRB reviews and other regulatory requirements. Clinical coordinating and managerial assistance is needed to conduct the Argentina study, Role of oxidant susceptibility genes in severity of neonatal diseases associated with hyperoxic injury. The purpose of this work assignment is to provide a research coordinator to assist the PI and study staff on-site in Buenos Aires, Argentina in conducting this study. This person will act as intermediary between Argentinian and US study staff, and the NIEHS OHRC. ? This coordinator shall be fluent in the native Argentinian language and English; ? This coordinator shall spend adequate amounts of time in Argentina (working with Argentinian study staff) to ensure that the study is being conducted following IRB and scientific protocols, and that subjects are adequately informed about study procedures and properly consented. This might include 3 visits to Argentina; the first visit might require 2 weeks and subsequent visits might require 1 week per visit; ? This coordinator will ensure that properly signed copies of consent forms are maintained and up-to-date, and that IRB paperwork and other approvals are up-to-date. This will include updating IRB documents (protocols, consent forms, data collection forms, and other study materials) as needed for IRB continuing review and amendments; ? This coordinator will submit up-to-date documents to the NIEHS IRB, and assist with submissions to other IRBs; ? This coordinator will ensure that accrual records are properly maintained and can be provided to NIEHS and other IRBs upon request; ? This coordinator will aid in translating correspondences and other documents between English and Spanish, to assist all study staff and IRS members in both countries; ? This coordinator will oversee Argentinian staff in obtaining Federal Wide Assurance from the NIH; ? This coordinator will spend adequate amounts of time in the U.S. working with OHRC and Vanderbilt staff to aid with U.S. IRS submissions, and coordinate study activities between U.S. and Argentina IRBs.