Kim Thi

Dynamic Lead Research Coordinator at Paragon Rx Clinical with expertise in pharmacovigilance and clinical trial management. Proven track record of enhancing research quality and securing funding through compelling grant proposals. Skilled in project management and mentoring, driving successful outcomes while ensuring compliance with ethical standards and regulations.

• Successfully coordinated and contributed to the clinical trial supporting the FDA approval of Shield, the first and only FDA-approved blood-based test for primary colorectal cancer (CRC) screening in adults aged 45 and older at average risk.
• Coordinated efforts for the FDA approval of Exact Sciences’ Cologuard Plus test, which sets a new benchmark in non-invasive CRC screening, enhancing early detection and prevention.
• Played a role in the successful FDA approval of VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL PAK® (vonoprazan-based therapies) for the treatment of Helicobacter pylori (H. pylori) infection in adults, by coordinating clinical trials and ensuring protocol adherence.
• Contributed to clinical research efforts supporting the FDA approval of VOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) in adults.

• A Phase 3b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide 290 μg Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients with Irritable Bowel Syndrome with Constipation

• A Phase 3, Randomized, Double-Blind, Two-Phase, Multicenter Study to Evaluate the Efficacy and Safety of XXX Compared to XXX for Healing in Patients with Erosive Esophagitis and to Evaluate the Efficacy and Safety of XXX Compared to XXX for the Maintenance of Healing in Patients with Healed Erosive Esophagitis

• A Phase 3 Randomized Multicenter Study to Evaluate the Efficacy and Safety of Open-Label Dual Therapy with Oral XXX or Double-Blind Triple Therapy with Oral XXX Compared to Double-Blind Triple Therapy with Oral XXX Daily in Patients with Helicobacter Pylori Infection

• A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

• A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Twice-Daily Oral Administration of a Peripherally Acting Dopamine Receptor XXX for the Treatment of Adult Subjects With Symptomatic Idiopathic or Diabetic Gastroparesis

• A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of XXX and XXX Compared to Placebo for Relief of Heartburn in Subjects with Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD) After 4 Weeks and to Evaluate the Efficacy and Safety of XXX for Relief of Heartburn in Subjects with NERD After 6 Months

• A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of XXX and XXX Compared to Placebo for Relief of Episodic Heartburn in Subjects with Symptomatic Non-Erosive Gastroesophageal Reflux Disease

• A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of XXX Administered Orally to Children Ages 6 to 17 Years With Functional Constipation (FC)

• Clinical Study of the Cue® Influenza Test with Lay Users Self-Testing in a Simulated Home Use Setting

• BIOCARD Pro Over-the-Counter Rapid Antigen Test for Detection of SARS-CoV-2 Virus: Clinical Evaluation