Biosketch
Susan Monane, BS, MSN
Susan Monane is Principal at Monane Group Clinical Consulting LLC since September 2015.
She has a Master of Science in Nursing degree with an active Certified Clinical Research Coordinator (CCRC) certification as well as more than 25 years of work in research and clinical care, including extensive day-to-day experience with clinical trials functions such as clinical operations and safety monitoring in the areas of oncology, cardiology, and women’s health. Susan has been part of research teams responsible for three successful FDA submissions and approvals.
With respect to her work in research, Susan has been involved in several phases of clinical drug development in both the academic and industry settings. Her first research job was a nurse researcher role in the Systolic Hypertension in Elderly People Project (SHEP) at Albert Einstein College of Medicine, Bronx, NY. In this role, Susan was involved in the development and execution of subject recruitment plans as well as ongoing communication with the other trial sites as part of the SHEP study. More recently, at Sanofi, Susan served as a Medical Reviewer prior to a Phase III database lock and was responsible for verifying appropriate reporting and documentation of adverse safety events for a diabetes study. At Roche, Susan was part of a Phase III team evaluating Actemra for rheumatoid arthritis and coordinated data management and queries of over 12,000 case report forms for the Actemra studies at Roche. At Innovative Clinical Solutions, Hackensack Medical Center, and the Hebrew Rehabilitation Center/Brigham and Women’s Hospital/Harvard Medical School, her work included Phase I-IV multisite trials including audits and oversight of outpatient research sites. With respect to her work in clinical care, Susan has a strong background in a variety of care arenas, including outpatient and inpatient geriatric and adult patient clinical care settings as well as long-term care settings.
Susan holds a B.S.N degree from Boston University School of Nursing, Boston, MA and a M.S.N degree with added focus on Geriatrics and Education from Hunter-Bellevue School of Nursing. She has been a Certified Clinical Research Coordinator since 2001. Susan has active nursing licenses in New York, New Jersey, and Massachusetts.