• Oversees regulatory management for investigator-initiated trials and industry-sponsored trials at the Preston Robert Tisch Brain Tumor Center and Duke Center for Brain and Spine Metastasis.• Successfully manages complex oncology trials utilizing vaccine, convection enhanced delivery, and immunotherapy-based investigational agents.• Collaborates and creates strong working relationships with industry sponsors and CROs including but not limited to Eli Lilly, AstraZeneca, BMS, IQVIA, Paraxcel, HCRN, ICON, and Criterium.• Participates in an internal regulatory working group for the development of a new e-regulatory binder system. Provides feedback and support for updated processes and procedures for new platform.• Works with principal investigators to draft and submit all regulatory documents, such as ICFs and eligibility checklists, for studies to Duke's institutional review board as well as the Western IRB when applicable.• Composes Investigational New Drug (IND) applications for submission to the FDA and maintains the IND through the life of the study.• Initiates and participates in study start-up activities, SIVs, and study close-out activities.• Manages study documentation for staff members including curriculum vitaes, licenses, financial disclosure agreements, and delegation of authority logs.• Ensures all faculty and staff adhere to GCP guidelines and are appropriately trained in delegated responsibilities.• Coordinates and facilitates monitoring visits and audits with internal and external CRAs.• Submits protocol amendments, consent form changes, continuing reviews, and other documents according to institutional and sponsor reporting guidelines.• Demonstrates expertise in Good Clinical Practice (GCP) and federal regulatory guidelines to ensure the highest quality research standards are met.• Ensures all study key personnel are adequately trained on new studies, protocol amendments, and other changes that may occur during the course of a trial.

• Responsibilities from Data Technician role also performed in this position.• Coordinated minimal risk studies and consented patients to data registry and biorepository studies.• Performed QC checks on patient study binders to ensure files and data were current and accurate.

• Worked in data collection for oncology clinical trials at the Preston Robert Tisch Brain Tumor Center.• Completed data entry within multiple electronic data capture systems including but not limited to OnCore, Medidata Rave, Oracle Clinical, and InForm.• Responded to data queries to ensure resolution.• Attended adverse event meetings and ensured prompt reporting of all serious adverse events.• Met deadlines required by the sponsor or required internally for database locks and interim analyses.• Developed data collection documents and guidelines to standardize processes.• Collected and shipped specimens to sponsors.• Prepared data for monitoring by internal and external CRAs.• Attended study start-up meetings and SIVs to ensure study data would correspond with patient and billing calendars• Mentored and trained junior data team members.