Marsha Greene, MS, MPhil, BS
Marsha Greene is an experienced clinical research professional skilled in clinical trials sponsor engagement, protocol and program development, regulatory oversight, and policy development. In her 14-year professional career, Ms. Greene has worked on a diverse array of projects encompassing infectious disease, cancer, socio-behavioral issues, and the impacts of emerging biotechnologies on human health and national security. Ms. Greene has a specific interest in research ethics and the protection of human subjects participating in clinical research.
Her most notable achievements include contributions to the 2018 Common Rule, which is the Federal policy governing the protection of human subjects in research. She also managed the clinical trial that led to the expanded use of Gleevec for Gastrointestinal Stromal Tumors (GIST). She also developed a framework for the National Minority Institute’s regulatory oversight program.
Ms. Greene has been involved in the clinical research process at multiple stages. She is particularly skilled at managing relationships and liaising with the full spectrum of research partners including Federal government partners, research committees, sponsors, and vendors. For example, she represented the Department of Defense in OSTP committees dealing specifically with emergency protocol development to address public health threats, including Ebola. Additionally, she has managed clinical studies from both the sponsor and the CRO perspective. This has provided her with a unique understanding of the needs and requirements of trials managed in different environments. She has contributed her expertise to both writing and reviewing research concepts, writing and developing protocols and other research documents and performing regulatory oversight for clinical research projects. She has demonstrated clinical research oversight skills such as developing and maintaining communication and data management plans, keeping track of project milestones, and taking a proactive approach to ensure the smooth running of her projects throughout their lifecycle.
Ms. Greene’s educational background reflects her career interests. She has earned Master’s degrees in Biomedical Science and Biomedical Ethics and is currently working on her doctorate in Biomedical Ethics. She is a published author and has represented her clients in multi-agency efforts to develop research policy. Most notably, she has worked directly on the 2018 Common Rule and has been involved in discussions on strategies for implementing emergency protocols to address public health threats such as ebola. She currently located in Belgium.
Currently, Ms. Green is supporting the American Society of Hematology Research Collaborative (ASH RC) in their efforts to connect with sponsors, determine their needs, and continue to build a sickle cell disease network (SCD).
Countries: Trinidad, Tobago, Belgium, and the United States
Languages: Fluent English; basic French and Spanish