•Manage the workflow and review processes for the biomedical IRB team, which includes 13 staff members, 8 of which are direct reports. •Oversees IRB administrative functions, including the hiring, supervising and training of IRB analysts, and IRB panel members. •Supervised the biomedical team and IRB panels transitioning to remote work, and remote board meetings during the COVID pandemic, including the timely review and approval of over 300 COVID related submissions. • Participated in FDA site visit, including directly working with the FDA inspector to collect documents, navigate eIRB+, and resolve queries. Also received a service excellence award for this site visit. •Assisted in securing AAHRPP reaccreditation, including contributing to the application, organizing interviews, interacting with site visitors, and formulating the response to the site visit report. •Maintains IRB Roster and IRB Registration with OHRP, which includes management of 90 IRB members over 6 IRB panels. •Completed Northwestern’s Managers Foundations course, which is a series of interactive classes designed to impart knowledge and develop skills to be a successful manager. •Manages issues and compliant resolutions related to IRB submissions and review process.•Coordinates and analyze the results of quarterly quality assurance reviews, of expedited submissions and panel meeting minutes. •Provides consultation to investigators, affiliates, and departments regarding IRB submission of more complex proposals.•Conducts presentations to the research community regarding the Northwestern University Human Research Protection Program. •Integral part of IRB Office leadership in accomplishing strategic goals, including coordination of the operations group meetings.

• Serves as the primary resource for regulatory and procedural guidance regarding questions and issues that arise from the day-to-day operation of the Biomedical IRB.• Provides regulatory, ethical and methodological guidance to researchers relating to the creation of IRB submissions and review.• Responsible for the training, and educating of new IRB panel members, and IRB staff on the electronic submission process, and the toolkit that is essential to the review process.• Responsible for the organization of monthly biomedical IRB panel meetings and preparation of meeting minutes.• Serves as IRB reviewer of complex biomedical research involving humans to ensure the safety, rights and welfare of participants are protected.

• Ensure research involving human subjects is reviewed and approved in compliance with federal regulations and state laws.• Responsible for the organization of monthly biomedical IRB panel meetings, and preparation of meeting minutes.• Facilitate resolution of issues between the IRB and Investigators, in order to secure approval of new projects, revisions and safety submissions.• Serve as IRB reviewer of minimal risk biomedical studies that meet exemption or expedited review criteria, and also minor modifications to previously approved research.• Conducted educational presentations to the research community on topics including consent form development, and conflict of interest.• Presented a poster at Public Responsibility in Medicine and Research conference on reducing length of IRB meetings.• Serve as a resource on human subject protections for the Northwestern research community, IRB members, and IRB staff.

• Responsible for securing initial IRB approval for protocols conducted at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.• Experience creating informed consent documents for phase I, II, III, and expanded access oncology protocols.• Maintained compliance by ensuring timely submission of study documents, including protocol amendments, and investigational brochures for oncology protocols. • Facilitated communication between Investigators, Sponsors, and IRB panels for protocols involving investigational new drugs, devices and laboratory studies• Active in the preparation of regulatory files for audit by the National Cancer Institute (NCI), and the Eastern Cooperative Oncology Group (ECOG). • Conducted audits of cooperative group sites affiliated with Northwestern University.• Participated as a protocol reviewer for the Clinical Protocols Scientific Review and Monitoring Committee of the Robert H. Lurie Comprehensive Cancer Center.

• Coordinated enrollment of participants onto phase I, II, III, and expanded access protocols.• Served as Study Chair Liaison for a cooperative group protocol for participants with recurrent or metastatic head and neck carcinoma. • Participated in the informed consent process of clinical research participants for oncology protocols, involving various types of solid tumors.• Collected data and completed case report forms for studies including academic in-house, cooperative group, and industry sponsored protocols.• Experience working in both outpatient and inpatient clinical settings.

• Consented subjects to participate in research evaluating impulse control in individuals with psychological disorders. • Administered and evaluated neuropsychological and psychophysical tests. • Analyzed and collated EEG data.