BRANY’s leadership team brings decades of experience to the table. They also share a strong commitment to furthering the fields of clinical research and human subject protection.
Chief Executive Officer
Paddy Mullen joined BRANY 2010 and reports directly to BRANY’s Board of Directors. Prior to joining BRANY Ms. Mullen founded DiscoveryOrtho Partners, a consulting and advisory firm focused on the orthopedic sector.
Ms Mullen developed her expertise in orthopedics and research starting in 1999 as Executive Vice President at Hospital for Special Surgery (HSS) in New York City, the leading orthopedic hospital in the U.S. At HSS, Ms. Mullen was instrumental in the creation of HSS Ventures, a technology development company focused on venture capital investment, clinical research, product development and licensing in both rheumatology and orthopedics.
Prior to joining HSS, Ms. Mullen served as Senior Vice President of Business Development for Continuum Health Partners in New York City. Ms. Mullen received a Bachelor of Arts degree from the University of Notre Dame and an MBA from Babson College.
Kimberly Irvine, CIP
Executive Vice President and Chief Operating Officer
Kimberly Irvine is the Executive Vice President and Chief Operating Officer of BRANY. Her responsibilities include coordinating and implementing business processes that enhance BRANY’s efficiency. Before her prior promotion to VP of Operations at BRANY, Kimberly was the Director of the Regulatory Department where her primary responsibilities were in Contracts and Budgets.
Ms. Irvine began her career in Healthcare Administration at the Weill Medical College of Cornell University and subsequently obtained a position as a Business Manager for the Department of Medicine at LIJ. She has 25+ years experience in healthcare and research.
Ms. Irvine graduated with honors from St. Johns University in Healthcare Administration. She has co-authored a book on the Health Insurance Portability Accountability Act (HIPAA) called, “Ensuring a HIPAA-Compliant Informed Consent Process,” and is a Certified IRB Professional.
Executive Vice President and Chief Financial Officer
Joanne Nicholson runs BRANY’s Finance Department and oversees a team of staff dedicated to the financial oversight of each and every clinical trial. Ms. Nicholson is responsible for all aspects of fiscal management at BRANY, including budgeting, financial reporting, cash management and implementing fiscal policies and procedures. As a part of this process, Ms. Nicholson oversees Hospital and Investigator site payments, ensuring that all payments are made accurately and in a timely manner.
Prior to joining BRANY, Ms. Nicholson was a senior manager with KPMG, LLP where she spent the first 10 years of her career servicing healthcare providers and pharmaceutical and biotechnology companies. In addition, she has chaired several committees, including the New York State Society of CPAs Healthcare Committee (Nassau Chapter).
Ms. Nicholson graduated with honors from Adelphi University and is a licensed CPA.
Karen Roth, JD
Ms. Roth’s primary responsibilities at BRANY include drafting and negotiating clinical trial agreements, including master agreements and confidentiality agreements for all phases of clinical research. With more than 10 year’s experience in the research industry, Karen possesses a keen understanding of the legal intricacies of clinical trial agreements, and is effective at achieving results that meet the needs of all parties represented.
Ms. Roth is a graduate of Cornell Law School.
Raffaella Hart, MS, CIP
Vice President, IRB and IBC Services
Raffaella Hart is the Vice President of IRB and IBC Services. She is a Certified IRB Professional (CIP) and has been involved in research administration for more than 15 years. She and her team facilitate BRANY IRB’s oversight of research involving human subjects and assure effective IRB operations. She and her team also facilitate BRANY’s Institutional Biosafety Committee (IBC) Services and Conflict of Interest review services. Ms. Hart had a primary role in the efforts leading to BRANY IRB’s full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and is responsible for maintaining the standards required by the accrediting agency. She is also a site visitor for AAHRPP.
Prior to joining BRANY, Ms. Hart was an administrative director for medical practices and several hospitals throughout the tri-state region at Financial Medical Management. Ms. Hart received a Bachelor of Science in Psychobiology from SUNY Binghamton, and Masters of Science in Healthcare Science with a focus in Clinical Research Administration from the George Washington University. Ms. Hart has published in relation to IRB ethics and regulatory issues in the IRB Advisor, The CenterWatch Monthly, The Monitor, and Seminars in Nuclear Medicine. She was also a contributing author for the book How to Work In and Within IRBs.
Michael Belotto, PhD, MPH, CCRC, CCRA
Director, BRANY Institute for Research Education
Michael Belotto is the Director of the BRANY Institute of Research Education. He also serves as a research compliance expert responsible for auditing sites to ensure investigators’ compliance with FDA regulations and ethical guidelines. He also serves on the BRANY Institutional Review Board.
Dr. Belotto worked as a paramedic in the New York City Emergency Medical Service 9-1-1 system for 10 years, with 7 years of experience in Hospital Administration.
Dr. Belotto is a graduate of New York Medical College where he completed a Masters in Public Health with a concentration in epidemiology. He completed his doctorate in Public Health at Walden University.
Carmela Shabazz BS, MS, CCRA
Director, Corporate Development and Operations Support
Carmela Shabazz is Director of Corporate Development and Operations Support for BRANY. Her responsibilities include Developing CRO/Pharmaceutical/Device company relationships and marketing BRANY services including; investigator networks by clinical specialty, study procurement, education programs, Central IRB, auditing and monitoring services.
Prior to joining BRANY, Ms. Shabazz held various positions in the Clinical Research field including Senior Manager of Corporate Clinical Research, Senior Manager/Manager of Clinical Affairs, and Clinical Research Associate at various Clinical Research Organizations and Pharmaceutical/Medical Device Companies.
Ms. Shabazz is a graduate of North Carolina Central University where she completed her Master of Science in Family and Consumer Science. She is a certified clinical research associate and has co-authored several clinical research publications.
Director, Clinical Trials Activation Team (CTAT)
Rosemarie Spiler is the Director of the Clinical Trials Activation Team, (CTAT). She oversees and assists with the day-to-day activities of study start up executed by the CTAT Department. She functions as the key contact person between pharmaceutical companies, sites, investigators and research coordinators for Regulatory, Contract and Budget issues. Ms. Spiler has over 20 years of health care related experience.
Prior to working at BRANY, Ms. Spiler was an Accounts Receivable Specialist at a large academic medical center.
Program Director, Medicare Coverage Analysis (MCA) and Research Billing Compliance
Alexi Morillo is the program director for the Medicare Coverage Analysis (MCA) and Research Billing Compliance department at BRANY. His department reviews clinical trial projects determined to be eligible for Medicare coverage under National Coverage Determination 310.1. They also work with research institutions to ensure projects meet the requirements of Medicare reimbursement for clinical trials involving devices and drugs. His staffs develop billing grids and provide the findings on BRANY MCA forms that provide a road map for billing items/services.
His department reviews clinical trial projects determined to be eligible for Medicare coverage under National Coverage Determination 310.1 and they work with research institutions to ensure projects meet the requirements of Medicare reimbursement for clinical trials involving devices and drugs. His staffs develop billing grids and provide the findings on BRANY MCA forms which provide a road map for billing items/services.
Before joining BRANY, Mr. Morillo worked closely with principal investigators and various research staff for six years at New York University (NYU) School of Medicine in various roles that included data management, Research Coordinator, Supervisor, and Clinical Research Management Coordinator. Mr. Morillo’s career at NYU began at the Cancer Institute before joining the institution’s central research office, Office of Science and Research Office of Clinical Trials. As a Clinical Research Management Coordinator, he managed a portfolio of over 200 clinical trials a year with responsibilities that included oversight of the budget, contract, and research project finances. Mr. Morillo also served on NYU’s Data Safety Monitoring Board and the Cancer Institute’s Internal Audit Committee.
Mr. Morillo also worked as a Clinic Coordinator and Quality Improvement/Compliance Associate at The Floating Hospital. He also served as Chairperson for the Safety and Compliance Committee and was a member of the Core Values Committee while at The Floating Hospital.
Mr. Morillo was a certified Clinical Research Coordinator by ACRP in 2007 and graduated from the University of Phoenix with a Master of Business Administration.
Linda Reuter is the IRB Director at BRANY. Her responsibilities include supervising the IRB staff and maintaining compliance with the IRB Standard Operating Procedures as well as applicable regulations. This includes supervising pre and post IRB meeting activities, expedited reviews, continuing reviews, protocol monitoring, continuing education, development of short and long term strategic goals for the organization, maintaining AAHRPP accreditation standards, policy maintenance and development, and training and mentoring of IRB staff.
Ms. Reuter began her career in IRB Administration at North Shore University Hospital Manhasset, currently part of Northwell Health. She held various positions within the Health System’s IRB program over a 20 year period. Linda formed IRB Consulting, LLC in 2012, providing IRB administrative services, training and education, audit services, and general consulting to numerous IRB programs, including BRANY and HRP Consulting Group, as well as several local institutions.
Ms. Reuter graduated with honors from SUNY Stony Brook with a M.S in Health Sciences. She holds a B.S. in Biology from SUNY Stony Brook, and an advanced certificate in Health Care Management. She published work related to her Master’s thesis on Lyme disease in the Journal of Immunology, is a contributing author for a book on How to Work With and Within IRBs, and has been a certified IRB professional since 2001.