I became involved with AMI shortly after the company’s inception which has offered me the wonderful opportunity to work in nearly all areas of the company, from oversight of individual physicians, to Corporate Healthcare, Suspension & Debarment, Education, Corporate and Conflicts of Interest matters.
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Cynthia attended Northern Essex Community College (HON)
In which of AMI's service areas have you worked?
We know all of our team members see AMI's work from a different angle and have different perspectives on what AMI brings to the table.
What aspect(s) of AMI's work are you personally most passionate?
I enjoy the field work where we conduct on-site visits, interviews and focus groups, listening to those who may be most impacted by the decisions and possible sanctions of oversight agencies. This is where we are able to assess how in touch the leadership of an entity is with their management and support staffs and can work with clients to identify areas that are most vulnerable to non-compliance. Another area that I particularly enjoy is mentoring those new to monitoring practices and procedures which is often a new concept in many professional fields.
How do you believe your unique background affects the way you view our work, and in what ways does your personal expertise complement our services?
AMI works with all levels of regulatory oversight: local, state, federal, and global, to ultimately help the individual clients and their employees better serve the communities in which they do business. I served as Chairman of the Board and Founder for an Institutional Review Board for seventeen years, whose purpose, like AMI’s, was to protect the rights and welfare of individuals who participate in clinical trials while maintaining the highest standards of global regulatory oversight. In addition, I have worked with numerous pharmaceutical companies and medical device companies to develop compliance policies and processes which is exactly what AMI offers for a much broader range of professions. Another area where my prior experience fits particularly well was when AMI became the Conflicts Manager for a global non-profit partnership accelerating antibacterial products to address drug-resistant bacteria, which included funders such as the Bill and Melinda Gates Foundation, the UK Welcome Trust, Germany’s Federation of Education & Research (BMBF), and the US National Institute of Health. The regulatory requirements surrounding COIs in the clinical research world are extensive and I’ve been identifying and managing COIs for over 25 years, including individuals, corporations, and government agencies.
Based on your experiences, what would you like prospective clients to know about AMI?
Although it can be challenging and often takes restraint, AMI has a commitment to being caring but also impartial, finding that exact balance between the implementation of judgments and settlement agreements while honoring the client’s business interests. Another commitment that AMI makes is that of having collegial working relationships with all parties involved.
“AMI has a commitment to being caring but also impartial, finding that exact balance between the implementation of judgments and settlement agreements while honoring the client's business interests.”
Do you teach and/or conduct seminars, speak at conferences, serve on boards, or participate in volunteer work?
I am responsible for most of the training conducted by AMI, including Codes of Conduct and Compliance Training, Compliance Officer Training, and Ethics and Culture Training.
I also speak and conduct trainings on Good Clinical Practice (World Health Organization, GCP), Record Keeping, Board of Director Training, How to Prepare for FDA Audits, and a variety of other topics.
I am also a Volunteer for MA Responds, administered by the MA DPH, which integrates local, regional, and statewide volunteer resources to identify, credential, train, and mobilize volunteers during a health-related emergency or event.
What interests do you have outside of work?
I enjoy travel, new experiences, good food & wine, entertaining, reading, theater, movies (from silent to current), music, dance, and time spent with friends and especially my grandchildren.