Laura has more than 30 years in healthcare starting her career in the operating room as a surgical technician to put herself through nursing school after which she worked as an ICU nurse at Cleveland Clinic and Massachusetts General Hospital. She made the transition to clinical research at the Harvard ACTG at MGH as a research nurse and later into drug development at Eli Lilly in1998. She has been in the biopharma industry, working in drug development in clinical operations, clinical compliance, and clinical quality assurance since that time.
Laura is a known trusted advisor and expert in GCP quality assurance, clinical operational risk and CRO/vendor oversight, risk-based quality management (RBQM) and clinical monitoring, clinical research bioethical assessments, ICH E3, ICH E8, ICH-GCP E6 (R2), ICH Q8–10, 21 CFR § 312, 45 CFR § 46,21 CFR § 11, NDA, BLA, and BTD submissions. She is also a known expert advisor and expert witness in fraud and securities litigation related to clinical research development.
Laura is an inductee into the National Society of Leadership and Success (nomination by The George Washington University, 2021), Alpha Eta National Honor Society (nomination by The George Washington University, 2018), and Golden Key International Honour Society (nominationby The George Washington University, 2018). Laura is a Registered Nurse and has a BS in Biology, a Master’s Degree in Clinical Research Administration, and is finishing her PhD in Translational Health Sciences.