Alyssa Pingitore

• Perform Quality Assurance (QA) reviews of human subject research studies conducted at Boston University Medical Campus (BUMC) and Boston Medical Center (BMC). Areas of review focus include but are not limited to informed consent process, participant eligibility, and regulatory documentation.
• Communicate with investigators to schedule QA reviews, lead meetings about study conduct and documentation, and provide final QA review reports. QA review findings include major and minor deviations and best practice recommendations.
• Disseminate QA review findings to appropriate institutional stakeholders, including but not limited to Office of Human Research Affairs (OHRA) Director, Institutional Review Board (IRB) Director, Institutional Privacy Officers, and Research Compliance Officer.
• Counsel investigators on tasks such as notifying the IRB and/or study sponsor of reportable events, creating a Corrective and Preventative Action Plan to improve research conduct, and crafting protocol amendments.

Research content: NIH/NIAAA-funded randomized controlled trials investigating novel pharmacological treatments for alcohol use disorder.

• Recruited participants in the target study population via multiple outreach methods (online posting, flyering, etc.) and performed telephone screening for eligibility.
• Conducted data collection tasks including but not limited to participant interviews/questionnaires, neuropsychiatric testing, vital signs, and electrocardiogram.
• Manage communications within the study team and with external research personnel such as the Institutional Review Board (IRB) and study sponsors.
• Collaborated with team biostatistician to perform data analysis on completed datasets. Independently performed quantitative data analysis for a publication.