CDR Nicole Bell’s career at the FDA began in 2009 in the Office of Regulatory Affairs (now Office of Inspections and Investigations) as an investigator performing foreign and domestic inspections of firms conducting clinical and non-clinical research trials. She spent two years as a compliance officer in the Center for Devices and Radiological Health monitoring inspection assignments and initiating administrative actions in cases of significant departure from regulations governing the protection of human subjects and investigational device exemptions. She returned to the field in 2019 and is currently a Branch Chief in the Office of Bioresearch Monitoring Inspectorate (OBMI) managing a highly experienced cadre of national and program experts, liaising with FDA product centers in support of agency-wide bioresearch monitoring operations and overseeing the issuance of over 750 domestic inspections performed annually. CDR Bell holds a Bachelor of Science in Biochemistry from Xavier University of Louisiana, a Master of Science in Analytical Chemistry from Louisiana State University and is currently pursuing a Doctor of Public Health from the University of South Florida.

Christine serves as the Division Director for Division 2 in the Office of Bioresearch Monitoring Inspectorate within FDA’s Office of Inspections and Investigations. She leads a team of professional investigators, branch chiefs, and support staff who collaborate with FDA’s product centers to conduct inspections of clinical and non-clinical trials, post-market adverse drug experiences, and risk evaluation and mitigation strategies.

Ms. Smith joined FDA in 1992 and holds a Bachelor of Science in Biochemistry and Molecular Biology from UMBC in Baltimore, MD. Her career began as a student trainee physical science technician in the former Baltimore District Laboratory. Throughout her tenure, she has held diverse roles including chemist, investigator, bioresearch monitoring specialist, training officer, supervisor, special assistant to the deputy associate commissioner for regulatory affairs, and director of investigations. She is passionate about continuous improvement and collaboration to promote efficiencies and best practices.

Vanessa Coulter is a Program Expert within the Office of Bioresearch Monitoring Inspectorate at the Food and Drug Administration (FDA), with more than 15 years of experience in bioresearch monitoring, clinical research compliance, and inspectional oversight. In her current role, she supports inspection activities and contributes to an array of cross-functional workgroups focused on training, inspection development, and compliance strategy. Prior to her current position, she served as an FDA investigator for over a decade, conducting more than 300 inspections worldwide. She holds a B.S. in Food Science from Clemson University.

Matthew R. Coleman is an Investigator with the Office of Bioresearch Monitoring Inspectorate (OBMI) at the U.S. Food and Drug Administration (FDA), bringing over a decade of regulatory compliance experience conducting domestic and international inspections focused on data integrity, human subject protection, and federal regulatory compliance — including Clinical Investigator (CI), Institutional Review Board (IRB), Postmarketing Adverse Drug Experience (PADE), and Risk Evaluation and Mitigation Strategy (REMS) inspections. Before joining the FDA, he spent 11 years in Environmental Health conducting regulatory inspections across food and public health settings. He holds a Bachelor of Science in Biology and is committed to strengthening communication between regulatory authorities and clinical research professionals to promote Good Clinical Practice (GCP), research integrity, and the protection of study participants.

Anthony Grace is an Investigator with the Office of Bioresearch Monitoring Inspectorate at the U.S. Food and Drug Administration. He has been with the FDA since 2021, conducting dozens of OBMI inspections both domestically and internationally. Prior to his role as an Investigator, he was a Medical Technologist for other Federal Agencies and served in the U.S. Army for 12 years. Anthony holds a Bachelor’s degree in clinical laboratory science and a Master’s in Healthcare Administration. When not conducting inspections, he enjoys spending time with his family, watching his favorite sports teams, and listening to music.

Alyssa Gateman currently serves as the Executive Director of the Yale Cancer Center Clinical Trials Office. Since joining Yale in July 2014, she has also held the role of Senior Associate Director of Quality Assurance and Research Regulatory Initiatives at the Yale Center for Clinical Investigation. Prior to her time at Yale, Ms. Gateman was Director of the Quality Assurance Office for Clinical Trials at Dana-Farber/Harvard Cancer Center.

Ms. Gateman is deeply committed to advancing the clinical research workforce through education and mentorship. In addition to her long-standing involvement with SOCRA, she serves as Adjunct Faculty at Southern Connecticut State University, where she teaches Good Clinical Practices and Clinical Trial Administration as part of the Healthcare Studies undergraduate program. A dedicated SOCRA member, she will celebrate 22 years of membership and 19 years of certification in 2025. She is a former SOCRA Board member, frequent presenter for SOCRA and currently serves as the inaugural President of the Connecticut SOCRA Chapter.

Outside of work, Ms. Gateman enjoys supporting the Yale Junior Bulldogs hockey team as a coach’s wife and goalie mom, and spending time with her golden retriever, Biscuit.

Jessica Rowe, MA, MS, CCRP, CIP, is the Quality and Education Director for the Yale Cancer Center Clinical Trials Office. Previously, she served as the Associate Director for Regulatory, Compliance, and Quality at the Yale Center for Clinical Investigation (YCCI) and the Yale Human Research Protection Program (HRPP). Before her tenure at Yale, Jessica was the HRPP Director for WellSpan Health, where she managed a comprehensive human research protection program.

Jessica has an extensive 13-year background at the University of Maryland, Baltimore (UMB), where she held multiple roles in the research field and was an active member of several research review committees. She continues to contribute as an IRB member for both UMB and Yale, and she chairs the Southern Pennsylvania SOCRA Chapter while also serving as the Immediate Past President of SOCRA.

Jessica is an adjunct instructor at the University of Maryland, Baltimore Graduate School, teaching courses in research compliance and administration. She is a recognized faculty member in several SOCRA workshops, including Quality Management and the GCP Prep Course.

With extensive experience in human subject research compliance, IRB, quality, clinical trial management, education, and training, Jessica is a Certified Clinical Research Professional (CCRP) and a certified IRB Professional (CIP). She also holds a graduate certificate in Research Ethics from the University of Maryland, Baltimore. Her passion lies in human subject protections, bioethics, quality, and compliance.