• Shepherd protocols through the DSMC and IRB review processes to achieve a timely outcome that is compliant with applicable regulations. • Be responsible for managing the review of new protocols, amendments, progress reports, monitoring reports, audits, serious adverse events (SAEs), deviations, unanticipated problems and other reportable events. • Prepare materials for committee meetings for assigned protocol submissions ensuring completeness and supplement the packets with relevant reports, e.g., SAE and deviations reports. • As requested, assist in preparing materials for internal and external audits and accreditations and ensure assigned protocols are ready with appropriate documentation is filed, current and compliant with internal and external requirements. • Identify areas for process improvement and efficiencies that also support regulatory compliance. • Participate as requested in quality improvement initiatives which may include but are not limited to policy and/or procedure development or updates, electronic form revision in iRIS, workflow updates and report and dashboard enhancements to support daily operations.