Indiana University School of Medicine (IUSM), Division of Gastroenterology & Hepatology is seeking qualified candidates who are passionate about IRB and Regulatory. This opportunity is perfect for an organized individual that is seeking work/life balance & great benefits while utilizing your skills and experience. This candidate will provide IRB and regulatory support to our research teams. This position will participate in the initiation, monitoring, completion, and reporting of routine to moderately complex clinical studies in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP). It will also create and maintain regulatory documents for numerous clinical research studies and enter regulatory data for various trials.
The IU Division of Gastroenterology & Hepatology has a distinguished tradition of excellence in patient care and innovation in research and education. Consistently ranked among the top 15 units nationally by US News and World Report, we are one of the largest divisions in the country with enormous breadth to our clinical and research expertise.
This position will complete initial protocol submissions to IRB and other internal and external regulatory boards. Utilize KC-IRB to complete all IRB required documentation: questionnaires, consents (study and HIPAA), Investigators Brochure, advertising, protocol and other documents as needed, and all the copies. Complete and submit amendments, continuing reviews, and safety reports. Keep Investigators and clinical research staff updated on status of IRB submission, review, approval, and regulatory documents. Coordinate contacts among research staff, investigators, federal regulatory agencies, senior administrators, research sponsors and research review boards to achieve timely review and approval of research projects.
REQUIRED: Bachelor's Degree in science or health-related field, plus 1 year health-related or research experience; OR Bachelor's Degree in any other field/Associate's Degree in allied health professions, plus 3 years health-related or research experience or 2 years' experience in clinical research.
SOCRA or ACRP certification.
Salary Plan: PAO
Salary Grade: 2RS
Campus: IUPUI - Indianapolis
Department: GASTROENTEROLOGY (IN-GAST-IUINA)
Internal Number: 68728
About Indiana University
Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.