Therese Capobianco Tallini

Accomplished research coordinator with extensive experience in drug development clinical research and managerial work. Knowledge and experience in GCP based on FDA regulations, IRB policies, site qualification, site monitoring, and study close out visits, EDC systems, and seeing research patients. Demonstrated business acumen, and uses scientific knowledge and strong analytical skills to support business objectives and solve problems.

• CITI training program 2015
• NIH, Protecting Human Research Participants Training Course 2015
• IATA Training 8/2017
• Study related training: Rave, In-form, Various dates

• Responsible for initiating, coordinating and managing research studies conducted
• Overseeing budget and protocol development for studies
• Patient recruitment based on summarization, screening and verification of eligible patients through medical chart review
• Completing Case Report Form (CRF)
• Maintaining study specific supplies and shipping of lab specimens according to biohazard regulations
• Preparation and maintenance of study supplies, and drug accountability log
• Preparation and submission of regulatory documents to IRB and Sponsor, preparing study documents and maintaining files according to sponsor requirements
• Preparation of site and all documentation for SIV, monitoring visit and study closeout visit
• Developing draft budget together with the office of clinical trials. Participating in justification of budget, confirmation of budget cost, and feasibility
• Clinical competency in performing EKG, phlebotomy, fibroscan, centrifuge handling, storing and shipping

• CB8025-21629: An 8-week, dose ranging, open label, randomized, Phase 2 study with an 18-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis CB8025 (PBC) and an inadequate response to or intolerance urso (UDCA) Cymabay
• A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Genkyotex
• A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to (NASH) Gilead Stellar 4
• A Phase 3, Double-Blind, Randomized, Long-Term, Placebo Controlled, Multicenter Study Evaluating the Safety and Efficacy of Stanca Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis (NASH) (747-303) Intercept
• A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with (NASH) and Bridging (F3) Fibrosis Gilead Stellar 3
• STELLARIS: A Phase 3, Multicenter, Randomized, Double-Blind, Tobira 516-01976 Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with AURORA Nonalcoholic Steatohepatitis Tobira Aurora
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects (NASH) Cirrhosis and Severe Portal Hypertension IDN 6556-14 Conatus
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Decompensated (NASH) Cirrhosis IDN 6556-17 Conatus
• A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-Making for Patients, Providers, and Florida Stakeholders University of Florida
• CENTAUR - Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects with Liver Fibrosis Medpace Tobira
• HCV Target A Phase 3b, Multi-Center, Randomized, Open-Label, Pragmatic Study of Glecaprevir/Pibrentasvir (G/P) +/- Ribavirin for GT1 Subjects with Chronic Hepatitis C Previously Treated with an NS5A Inhibitor + University of Sofosbuvir Therapy University of Florida