People
Regulatory Specialists
The TNC Regulatory Core supports research teams throughout the entire lifecycle of a clinical study. They assist with preparing and submitting IRB applications, amendments, continuing reviews, and reportable events while providing guidance on regulatory requirements and institutional policies. Throughout the study lifecycle, they assist with study startup activities, including site initiation, and remain involved through study closeout. Their responsibilities also include developing and managing reliance agreements between research sites and hospitals, maintaining electronic regulatory binders in systems such as SiteVault and eReg, and reviewing regulatory and patient binders to help ensure they are complete, organized, and audit ready. In addition, the team supports FDA regulatory submissions, including initial submissions, adverse event reports, and annual reports.
Ashley Dever, MPH
Regulatory Compliance Specialist
Ashley Dever is a Regulatory Compliance Specialist for the Translational Neuroscience Center (TNC). She received her Master of Public Health in Epidemiology and Biostatistics from Boston University. She has six years of clinical research experience. She previously worked as a Quality Management Specialist and Clinical Research Assistant at BIDMC. In her current position, she supports regulatory maintenance, ensures study compliance, and assists with study start-up.
Marwa Elborki, BA
Regulatory Compliance Specialist
Marwa has over five years of experience in clinical research. In her current role, she supports study start-up, site initiation, and regulatory maintenance, ensuring compliance with institutional, local, and federal requirements. She also works closely with sponsors, including pharmaceutical partners, to support the successful execution of clinical trials. Before her current role, Marwa served as a Clinical Research Manager at Boston Children’s Hospital, where she led teams and oversaw complex, multi-site pediatric studies. She also led clinical trials at BIDMC and Johns Hopkins, guiding each study from planning through execution and collaborating across institutions.
Marena Neggers, MPH, CCRP
Regulatory Compliance Specialist
Marena Neggers is a Regulatory Compliance Specialist for the Translational Neuroscience Center (TNC). She received her BS in Health Sciences and Biology and Master of Public Health from Boston University. In her position, she works on study start up, site initiation, and regulatory maintenance. Marena has 5 years of clinical research experience working as a Human Research Quality Manager at Boston University and as a Research Coordinator at MGH.