Essential Functions: Preparation and submission of new regulatory documents for clinical research studies to the IRB and the study sponsor with 2-3 weeks of assignment and continuations 2 months prior to expirationPreparation and submission of ongoing regulatory documents for clinical research studies to the IRB and the study sponsor with 2 weeks of receipt from sponsor.Enter all components of regulatory into the university clinical research management software inclusive of but not limited to OnCore as soon as completed.Duties may include but are not limited to: protocol review for the purpose of developing informed consent and protocol summary documents, submission of protocol amendments, continuations, closures, reviewing adverse events, tracking of IRB renewal dates, interacting with physicians, research staff, IRB personnel, sponsor personnel
Qualifications: Bachelor's degree in science or health care fieldExcellent command of the English language, some familiarity with scientific and/or medical terminology Excellent writing skills.Detail oriented and strong organizational skills.Proficient in computer software utilization Microsoft office (Excel, Word, Access) Comfortable working and learning new software.Knowledge of clinical research desirable but not necessary.Working knowledge of Oncore software very desirable .Regulatory and IRB Experience very desirable.
Internal Number: 76_206818
About Wayne State University
Founded in 1868, Wayne State University is a nationally recognized metropolitan research institution offering more than 400 academic programs through 13 schools and colleges to nearly 32,000 students. Wayne State?s main campus in Midtown Detroit comprises 100 buildings over nearly 200 acres; its five extension centers offer higher education to people throughout Southeast Michigan. Wayne State is dedicated to preparing students to excel by combining the academic excellence of a major research university with the practical experience of an institution that by its history, location and diversity represents a microcosm of the world we live in. Reflecting its location and the excellent international reputation of its graduate schools, particularly in the sciences, Wayne State boasts the most diverse student body among Michigan?s public universities. Its students represent 49 U.S. states and more than 60 countries.