About Us » Founders & Management:

Peter N. Madras, M.D., F.A.C.S.
Chairman of the Board of Directors, Asentral, Inc. IRB

Dr. Madras graduated as a university scholar from McGill University School of Medicine in 1965. Until 1969, he headed the Biomedical Program at the Avco-Everett Research Laboratory, leading in the development of the intra-aortic balloon for treatment of cardiac failure, still widely used today. Dr. Madras trained in surgery at Harvard and the University of Toronto. He practiced as a transplant and vascular surgeon at the New England Deaconess Hospital and associate Professor of surgery at Harvard Medical School for 25 years. He was Medical Director of Grace Biomedical participating in the development of hybrid artificial organs. Dr. Madras served as member and Chair of the Massachusetts Board of Registration in Medicine. Dr. Madras retired from the active practice of surgery in 2001, and is currently research staff at Lahey Hospital. He founded the Medical Record Bank in 2001, a patient controlled medical record company, and he serves on the board of two start-up companies. He is a lecturer at the MIT Business School (The Sloan School) and was elected president of the Medical Development Group of Boston, a 400 member organization of professionals dedicated to medical devices and technology. Up until 2012, Dr. Madras served as a Chairman of the Asentral, Inc. IRB and now is the Chairman of the Asentral, Inc. IRB Board of Directors.


Richard J. Clunie, B.A., M.S.A.
CEO

Officer of the Board of Directors, Asentral, Inc. IRB

Rick Clunie is the CEO of Asentral, Inc. IRB and an officer on its Board of Directors. Rick graduated from Colby College with a BA in Environmental Studies and has his Masters of Science degree in Accounting. Before joining Asentral, Rick founded several of his own companies, serving as owner and President in each case. He has a history of launching new ventures and guiding them through sustained growth and success. Rick also served as Vice President of Operations, Quality Manager and International Service Manager for two global manufacturers of industrial capital equipment. Since 2003, under Rick's guidance, Asentral IRB has reviewed a wide range of diverse studies, varying from multi-center Cancer Trials as part of the National Cancer Institute's Cancer Trials Support Unit (CTSU program), to new investigational drug and medical device studies, psychiatric studies and non-medical human factor studies. Rick has been a frequent presenter at local, regional, and national clinical research symposiums addressing the issues surrounding the commercial IRB and the clinical research industry. Rick is a member of the American Institute of Certified Public Accountants and serves as a member of the Northern Essex Community College Clinical Research Coordinator Program Advisory Board.


Cynthia L. Owens, M.A., C.C.R.C.
Vice President /Co-Founder

Officer of the Board of Directors, Asentral, Inc. IRB

Beginning her career in the medical field in 1989, Cynthia has been focusing specifically upon clinical research since 1994. Cynthia is a nationally recognized expert on Patient Recruitment, having served as lead coordinator for over 28 studies in various indications. In addition to co-founding Asentral, Inc. IRB, Cynthia owns and operates a national consulting service, which integrates patient recruitment with clinical operations to improve the overall performance within each research site's unique culture. She has written and implemented standard operating procedures, recruitment plans, staff training manuals, quality assurance guidelines and directed all aspects of public relations for independent clinical research sites. A featured speaker at national symposiums on good clinical practice, Cynthia is recognized as a leader in her field.

Cynthia also does project management and training for a company that specializes in monitoring licensed practitioners and businesses that have been sanctioned by oversight agencies. She helps licensed professionals to continue practicing while they are also learning how to comply with state and federal regulations. Cynthia is also a member of the Northern Essex Community College Clinical Research Coordinator Program Advisory Board.


Karen A. Konisky, B.S., M.B.A.
Co-Founder

Karen has over 25 years of experience in Clinical Research. After graduating from the University of Maine with a degree in Biochemistry, Karen worked at Children's Hospital in Boston doing research for the Hematology/Oncology Department for 3 years. After a year at Massachusetts General Hospital's Pulmonary Department, she worked as a Clinical Research Associate for Fisons Pharmaceuticals. During this time Karen earned her M.B.A. at Boston University, and in 1989 launched her own Clinical Trials Consulting business. In 1990, she also started Sitebase Clinical Systems, a remote data entry software business, where she served as vice-president until 1997. Karen has been involved in many aspects of phase I through IV clinical trials, giving her a unique appreciation for the complexities and challenges facing the Pharmaceutical Industry.


George Ellison, B.A.
Board of Directors, Asentral, Inc. IRB

George H. Ellison, Jr. served on the Asentral, Inc. IRB as early as 2002 and continued on for many years before retiring from the IRB to serve as business advisor to the organization. George continues his involvement with Asentral, Inc. IRB by serving on the Board of Directors. He is a Financial Advisor with The New England Financial Group based in Waltham, Mass. George is a 1979 graduate of Lafayette College and started with the firm in 1979 as a Financial Planner, holding several positions until becoming Managing Partner in 1986. In 2002 George stepped down as Managing Partner, but remained with the firm to work more closely with his clients. His focus is in the areas of Wealth Management and Retirement Planning to 'Small Closely Businesses and High Income Professionals.'

George is recognized as a leader in the community through his generous involvement in many civic and charitable committees as a volunteer and fundraiser. Some of those activities include:

Chairman Anna Jaques Community Health Foundation, Newburyport, MA.
Chairman Board of Trustees Anna Jaques Hospital, Newburyport, MA.
Board Member of The Salem State University Enterprise Center, Salem, MA.
Founding Member North Andover Educational Foundation, North Andover, MA.
Campaign Chairman of North Shore Division of Mass Bay United Way.
Board of Directors Merrimack Valley YMCA, MA.
Chairman of St. Michaels Parish Capital Campaign, North Andover, MA.
Governor's Council-Governor Dummer Academy in Newbury, MA.
Board Member of The Firehouse Center for the Arts in Newburyport, MA.


Ernest A. Carabillo, Jr. B.S. Pharmacy, J.D.

After graduating from St. John's College of Pharmacy and the St. John's Law School in NYC he practiced both professions. Specializing in defense work in medical malpractice and product liability while becoming an attorney for the Village of East Rockaway in Long Island, he was hired by the Bureau of Drug Abuse Control in the FDA in Washington DC. After managing several divisions dealing with research and the scheduling and production quotas of controlled substances, he finished his government career in the Office of Drug Abuse Policy in the White House as an Associate Director for Regulatory Affairs. During his career, he was a "Visiting Professor" at both Howard University in Washington, DC and St. John's College of Pharmacy and Allied Health Sciences. He spent many years in major medical device and drug firms in senior positions managing regulatory and quality programs. His last position before starting his own firm specializing in "Crisis Management & Compliance" for the medical device industry, was Corporate VP for Regulatory & Quality Programs for Baxter Healthcare. In his new firm, "EXPERTech", he led a group of experts in assisting companies in North America and Europe when problems arose with regulators or when they wanted to strengthen their own activities.


Raymond A. Konisky, B.S., M.B.A., Ph.D.
Regulatory Affairs and Quality Systems

Ray serves as the Asentral Director of Business Development and as an advisor to the Board of Directors. Ray was founder of a scientific clinical data company that helped adopt, establish and implement new electronic clinical data collection standards for some of the world's largest pharmaceutical companies. He also has extensive expertise in scientific protocol design and data analytics. In addition to Business Development activities, Ray is assisting in Asentral's accreditation process with AAHRPP. Ray received his B.S. from the University of Maine, his M.B.A. from Boston University and his Ph.D. from the University of New Hampshire.


Michelle K. Binzel, B.A., Ph. D.
Business Development

Michelle brings to Asentral over 25 years experience in helping companies formulate and implement strategies. She earned her B.A. in Economics and International Studies at Macalester College in St. Paul, Minnesota. After several years at Sheshunoff and Company, consulting with small and medium sized banks, she went on to earn her Ph.D. at the University of Texas at Austin, specializing in Strategic Management. For over a decade, Michelle taught Corporate Strategy at Bentley University in Waltham, MA. Michelle joined the team at Asentral, IRB in 2014.

Michelle also brings many years of experience in the leadership of non-profit organizations. She is currently Board Chair of The Concord Chorus, Concord, MA, and previously, Parish Council Chair of St. Brigid Church, Lexington, MA. She served on the State Board of Suzuki: MA and is a leadership team member for the Eastern Massachusetts region of Guiding Eyes for the Blind.


Jennifer Brown, B.S.
IRB Staff

Prior to joining Asentral in 2011, Jennifer worked in business development for small to mid-sized companies, including co-founding a parts distribution company that managed over 60,000 parts in the commercial and industrial sectors of the turf equipment industry. She established a successful business-to-business dealer base and e-commerce site to market her company's products. Her background also includes business development for a commercial turf equipment distributor and a global manufacturing /outsourcing start-up venture. Jenn has a Bachelor of Science degree from the University of New Hampshire in Communication Disorders which included clinical hours at the Wentworth-Douglass Hospital in Dover, NH.


Kimberly Potts
IRB Adminstrator

Prior to being recruited to serve as the Administrator of the Asentral, Inc. IRB, Kimberly worked at the Massachusetts National Guard Family Program Office as a Family Readiness Support Assistant. Working directly with the Battalion and Unit Commanders of the Massachusetts' National Guard, she assisted in recruiting and training volunteer leaders to form Family Readiness Groups. These groups are designed to educate the families of soon to be deployed soldiers as to the pending adjustments to their family life and what resources are available to help them deal with these adjustments. Kimberly managed more than 45 volunteers and was responsible for 21 National Guard Units across the state of Massachusetts. She also has over ten years of administrative experience, teaching, counseling, and fund-raising for local churches and a mental health agency. A passionate contributor to her community and country, Kimberly's most recent volunteerism includes:

  • Associate Matron (similar to vice president) of the Order of Eastern Star of Ipswich, MA. Kim is slated to become the Worthy Matron (president) in April of 2015.

  • Vice President of the Angel Lights Association–Eastern division.

  • Chairperson of the Ipswich Community Clam Bake Group that raises funds for various local charity groups.

  • Chairperson of the Family Readiness Group for the 182nd Engineer Sappers of the Army National Guard in Newburyport.

  • Confirmation Class Teacher at the St. James Episcopal Church, Amesbury, MA.

  • Volunteer for the Episcopal Diocese of MA, Family Camp Staff.

Carol Hayes, B.S.
IRB Staff

Prior to joining Asentral, Inc. IRB Carol had over 25 years of experience working in the travel industry. Carol's career includes over 15 years at Delta airlines working as a sales and customer service agent. Her background also includes working for a worldwide travel agency where she was responsible for coordinating large international group travel as well as securing contracts with international vendors.

Carol has a Bachelor of Science Degree in Criminal Justice from Westfield University which included an internship working with families in crisis.

Carol has many years of fundraising experience, serving on auction committees for several organizations which include:

  • The Perkins School for the Blind of Boston, MA

  • Windrush Farms of Boxford, MA; a non-profit providing equine assisted activities and therapies to children and adults with special needs, veterans, youth at risk, survivors of human trafficking and more.

  • St. Mary's School of Danvers, MA

  • The Pingree School of Hamilton, MA

  • The Karen Martin Memorial Fund commemorating Karen Martin who was lost aboard American Airlines Flight 11 on 9/11/2001.

Carol is currently involved in the Perkins Parent Community and Citizens Advisory Board.