Liz Simpson Email & Phone Number

Deerfield, Illinois, Us

Managed planned clinical trials and supported and oversaw clinical operation activities across the portfolio of clinical research programs in several neuroscience indications. Ensured all assigned operational trial deliverables were met according to timelines, budget, operational procedures, quality standards, SOPs and business guidelines.

Boston, Ma, Us

MGH McCance Center for Brain Health: Senior project management and oversight of all aspects of the clinical research program for the MGH McCance Center for Brain Health. This role included overall management of the portfolio of all clinical research studies from design/initiation to completion, including being the key liaison with the sites, study sponsors, IRB, CROs, vendors, regulatory agencies and all levels of study staff to ensure smooth operations of all research projects within the Center. Also responsible for educating and training staff regarding research compliance and protocols, ensuring unit and staff compliance with all applicable regulations, developing and maintaining study guidelines, templates and tools, and reporting to regulatory and funding agencies as required. Also responsible for research strategic planning, project development and creation of periodic reports to enhance the research mission of the Center. Other responsibilities included fostering and building multidisciplinary research collaborations both internal and external to the hospital including outreach and marketing, and planning and executing professional meetings and seminars. Other tasks involved assisting with talent recruitment and retention, working closely with grant managers to oversee research budgets/grants and spending, and advising and mentoring staff and collaborators on a variety of research projects.

Boston, Ma, Us

MGH Neurological Clinical Research Institute with 2 promotions. Promotion 6/2011 - 2017 to Senior Project/Program Manager/Assistant Director, promotion 6/2007 - 2011 to Senior Project/Program Manager, originally hired as Clinical Research Program Manager 2005 - 2007. Senior project management of NIH/NINDS, industry and Investigator-initiated multi-center clinical trials in the U.S. and Canada for the treatment of neurological diseases as part of the NCRI Clinical Coordination Center (CCC) including phases 1 - 3, IND/IDE drug, device, biologic and biomarker studies. Therapeutic areas have included rare neurological diseases such as ALS, Parkinson's Disease (PD), and pediatric spinal muscular atrophy, and other neurological disorders such as multiple sclerosis and stroke with a special focus working in ALS and PD research trials.

Brighton, Ma, Us

Cardiovascular Research Department: Monitored phase 1 and 2 Investigator-sponsored clinical cardiovascular research studies including stem cell and gene therapy trials, including performing study protocol training, drug accountability, site management and data monitoring and management activities to ensure compliance with FDA regulations, ICH guidelines and hospital policies and procedures.

Monitored phase 2-4 clinical pharmaceutical industry clinical research trials including ensuring protocol compliance and patient safety, case report form review, source documentation verification, data query resolution, and drug accountability to ensure compliance with FDA regulations, ICH guidelines and company SOPs. Therapeutic areas included: cardiology, psychiatry, anesthesia and obstetrics/gynecology.

New York, New York, Us

Monitored phase 2-3 clinical pharmaceutical clinical trials including site training, protocol compliance, patient safety, case report form review, source documentation verification and drug accountability to ensure compliance with FDA regulations, ICH guidelines and company SOPs. Therapeutic areas included: oncology, cardiology, reproductive endocrinology, gastroenterology, psychiatry, and organ transplantation research.

Minneapolis, Mn, Us

Monitored cardiac stent clinical trials including protocol compliance, patient safety, case report form review, source documentation verification and device accountability to ensure compliance with FDA regulations, ICH guidelines and company SOPs. Other responsibilities included protocol development, site selection, site training and management, clinical trial data management and analysis, safety and regulatory reporting, and providing input with respect to device modifications and new product development.

Boston, Ma, Us

Cardiac Electrophysiology Research Department, Cardiac Arrhythmia Service: Under the Director of the Cardiac Arrhythmia Service, coordinated, supervised and implemented all clinical research trials conducted by the Cardiac Arrhythmia Service. Protocols included phase 2 and 3 studies of antiarrhythmic drugs, cardiac defibrillators, pacemakers, lead systems and mapping/ablation catheters. Duties included working with study subjects to collect clinical data at study visits.

Us

Channing Laboratory, the Nurses' Health Study: Collected research data and processed blood samples for the Nurses’ Health Study, a NIH funded, Harvard University epidemiological study to assess risk factors for cancer and cardiovascular disease in women.