Amanda B. Email & Phone Number

Dedicated Clinical Research Program Specialist with over 15 years of experience managing large portfolios of complex clinical trials across all phases (Phase I-IV), from start-up to close-out. Extensive expertise in clinical trial management, regulatory affairs, and medical writing, with specialized knowledge in oncology, neurology, radiology, and immunology research for both pediatric and adult populations. Proven ability to lead cross-functional teams, develop and implement study protocols, and foster productive collaborations with health authorities. Skilled in training research teams on study coordination, data management, and regulatory compliance, including ICH GCP and HIPAA requirements. Demonstrated success in guiding teams to meet objectives aligned with institutional policies, sponsor requirements, and federal regulations. Continuously identifies opportunities for performance improvement, informed by insights from participation on Johns Hopkins University advisory committees, including the Clinical Research Education Committee and the Regulatory Specialist Committee. Dedicated to ongoing professional and educational development, currently pursuing a Master’s degree in Research Administration at Johns Hopkins University to further enhance expertise in clinical trial management, regulatory affairs, and international research. Passionate about advancing medical research through innovation and collaboration.