Tingting Duan, Ph.D Email & Phone Number

Cincinnati, Ohio, United States

● Manage and oversee clinical studies for biotech and Pharma in compliance with ICH/GCP guidelines and other regulatory requirements● Lead and manage cross-functional study teams to accurately coordinate clinical study activities● Review and provide input for Study Protocol, Investigator’s Brochure, Informed Consent Form, Case Report Form, Edit Check Specifications, Data Analysis Plan, Clinical Study Report● Collaborate cross-functionally to monitor study data related activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews● Assist Medical Monitors in preparation of the responses for PIs (Principal Investigators) and Regulatory Authorities● Manage site quality to maintain 100% compliance with ICH/GCP guidelines and study protocols, including direct supervision of Clinical Research Associates and monitoring deliverables● Lead the preparation for Investigator Meetings, Site Teleconference Meetings, DMC meetings● Assist TMF team in overseeing the entire TMF process, ensuring timely completion and accuracy of all essential documents● Assist in the preparation and submission of regulatory documents for US, Canada and EU

Florida, United States

● One of 2 Sub-Is reporting to the PI supporting the research site expanding from 2 to 10+ clinical studies ● Managed and oversaw 7 clinical studies from start-up to closeout, including 1 Treatment-Resistant Depression, 2 Major-depressive Disorder, 1 Opioid-Use Disorder, 1 Attention-Deficit/Hyperactivity Disorder, 1 Schizophrenia, 1 Alzheimer’s disease ● Assisted PI in developing and implementing 5+ Manual of Procedures per protocols to recruit participants and conduct study procedures ● Led in protocol implementation and study progress, keeping all stakeholders apprised of study progress● Oversaw and facilitated eligibility screening and enrolled 30+ participants within 6 months● Collected and entered clinical data into EDC system, ensuring 100% query resolution, 100% data accuracy and integrity● Prepared IRB and any other regulatory submission documents● Developed and monitored project timelines ranging from 2-4 years and study budgets

Jupiter, Florida, United States

● One of the three research fellows reporting to the research group leader responsible for leading three research projects ● Identified imbalance between excitation and inhibition in synaptic transmission and neural circuits in mouse model of autism spectrum disorder● Built a rat model of adolescent exposure to cannabis, identified cognitive deficits, brain structural and functional abnormality that persisted to adulthood● Led the projects by designing and performing experiments, analyzing data, preparing manuscripts, and presenting data at meetings

Ottawa, Ontario, Canada

● Investigated the effects of endocannabinoid signaling on major depressive disorder and the underlying mechanisms● Discovered a novel mechanism underlying anxiolytic effects produced by increasing endocannabinoid signaling