Sr. Clinical Quality Specialist
Ramona Lione has joined Hart Clinical Consultants (HCC) to provide clinical quality systems support. She is responsible for creating SOPs and a quality systems manual for HCC to ensure that regulatory requirements are met, and that studies managed by HCC are of the highest quality, and processes are consistent across studies.
Ramona brings over 30 years of experience in laboratory and clinical research. She has a multi-disciplinary BA in biology and psychology from the State University of New York, Stony Brook, where she also worked as a technologist in a neuro-endocrine molecular biology lab. She went on to the role of Clinical Research Coordinator for the Endocrine division’s clinical trials in conjunction with Pfizer, which led to being recruited as a CRA for biotech start-ups, first in wound-healing, then in AIDS vaccine development.
She moved to California in 1996 to work as a CRA, then manager, at Keravision, an ophthalmic device start-up whose first product gained FDA approval during her tenure. She subsequently joined Guidant, managing studies in all phases of development of multiple cardiovascular devices, and continuing on when Guidant was acquired by Abbott Vascular (AV).
She played a pivotal role in the development of the Clinical Quality Affairs function for both Guidant and AV, and had a key role in the development of quality systems, integration of companies acquired by AV, and globalization of policies, processes and procedures. She additionally has had responsibilities including leading internal and external audits, CAPA and vendor management, regular staff regulatory updates, clinical staff job descriptions, and staff training and development, including promotion of CRA certification and professional organization membership.