• Developed study protocols, ClinicalTrial.gov materials, IRB applications and amendments, regulatory binders, and new testing measures for principal investigators and research faculty • Prepared reports for data and safety monitoring boards (DSMBs), funding agencies, and the NIH• Documented and reported adverse events and protocol deviations to relevant monitoring boards • Built and managed HIPPA-compliant databases (RedCap), created data coding manuals for staff, and developed data entry guidelines• Performed regular audits on all study material and data collection to ensure research met high quality Good Clinical Practice (GCP) standards • Provided project updates regularly to leadership and monitoring boards about strategy, adjustments, and progress• Monitored study progress, suggested and implemented adjustments as needed after identifying areas for improvement• Aided in preparation and revisions of two successful R01 NIH grant proposals, including drafting and securing letters of support• Developed and managed detailed study timeline plans, bearing in mind external goals and commitments, study staff, and participant burden and availability • Determined staffing needs to ensure efficient coverage and recommend changes to staffing patterns as needed• Assisted PI in establishing and maintaining research collaborations within and beyond the institution

• Coordinated and supervised daily operations relating to departmental research projects and trials• Trained and supervised research assistants and ensured that staff operated in accordance with GCP• Ensured compliance with institutional policies and procedures as well as federal and state law and regulations• Oversaw research visits and data collection by research staff• Managed recruitment database and prepared regular reports for PI about participant outcomes • Securely managed and maintained study data, conducted regular back-ups of server and databases