Kimberly Irvine, CIP, CIM
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.
516-470-6914 • firstname.lastname@example.org
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.
Portia M. Rindos, RN, CCRC, CCRA
Director of Quality Improvement and Auditing
Portia Rindos is Senior Director of our Quality Improvement and Auditing team. Her responsibilities include auditing for regulatory compliance and GCP, monitoring of pharmaceutical, investigator-initiated and NIH trials. She is an expert in FDA regulations, ICH, OHRP and GCP. She is also a member of the BRANY Institutional Review Board. Ms. Rindos was a Nursing Care Coordinator for a Cardiothoracic Telemetry unit and Assistant Nursing Care Coordinator for a Intensive Care Unit.
Ms. Rindos graduated from Molloy College in 1977 with a BSN. She has co-authored on several publications resulting from clinical research.
516-470-6913 • email@example.com
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.
516-470-6909 • firstname.lastname@example.org
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.
516-470-6917 • email@example.com
Carmela Houston-Henry BS, MS, CCRA
Corporate Development and Operations Support Director
Carmela Houston-Henry 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. Houston-Henry 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. Houston-Henry 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.
516-470-6979 • firstname.lastname@example.org
Network Development Coordinator
Kari Stair is the Network Development Coordinator. She serves as the liaison between Sponsors, CROs and the Investigators. Her responsibilities are to oversee that all upcoming clinical trials are sited with the appropriate investigators. Kari is also involved in recruitment and expansion of BRANY’S investigator specialty network.
Her career began at Memorial Sloan Kettering Cancer Center, where she served as a Clinical Coordinator in the Department of Dermatology. In 2012, Ms. Stair transitioned to the Department of Psychiatry and Behavioral Sciences, where she held the position of Budget Associate. Prior to joining BRANY, she was a Clinical Coordinator at The Institute for Bladder and Prostate Research.
Ms. Stair is a graduate of Long Island University, C.W. Post where she completed her Master of Public Administration.
516-470-6901 • email@example.com
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.
516-470-6925 • firstname.lastname@example.org
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 the Biomedical Research Alliance of New York (BRANY). 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.
516-622-2042 • email@example.com
Donna Brower is the Accounting Manager of the Finance Department at BRANY. She is responsible for overseeing all departmental work and collaborates with the CFO to support overall departmental goals and objectives.
Her career began with Ernst & Young, where her responsibilities included planning and executing financial statement audit engagements. After servicing primarily healthcare providers, Ms. Brower joined South Nassau Communities Hospital, where she held the position of Controller.
In 2003, Ms. Brower continued her career at NeuroRehabilitation and Neuropsychological Services, PC ,(NRNS) as the practice’s Internal Accountant. At NRNS she managed all of the accounting functions and assisted the President in monitoring all aspects of the practice.
Ms. Brower graduated from Binghamton University with a Bachelor of Science degree in Accounting, and is a licensed CPA.
516-622-2044 • firstname.lastname@example.org
Relationship Manager – Clinical Trials Activation Team (CTAT)
516-470-6933 • email@example.com
Manager – Clinical Trials Activation Team (CTAT)
516-470-6962 • firstname.lastname@example.org
Relationship Manager – Clinical Trials Activation Team (CTAT)
516-470-6911 • email@example.com
Director – IRB
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.
516-470-6969 • firstname.lastname@example.org
Supervisor – IRB
516-622-2049 • email@example.com
Associate IRB Coordinator
516-470-6965 • firstname.lastname@example.org
516-470-6906 • email@example.com
IRB Submission Analyst
516-470-6975 • firstname.lastname@example.org
Billing and Collections Supervisor
516-470-6927 • email@example.com
Senior Billing and Collections Coordinator