Esmeralda Morales

Esmeralda is a motivated, customer-focused Site Manager with more than 6 years of experience in the clinical research and pharmaceutical industry. Her depth of experience managing clinical trials consists of Phase II, III, and IV trials including the implementation of study protocols, feasibility, site selection and activation, patient enrollment, quality monitoring, quality close-out activities, hiring and training appropriate staff, working alongside medical operations to analyze financial trends and assess site capabilities. Esmeralda holds a bachelor’s degree in business from the Universidad Centroamericana (UCA) from her native Nicaragua. She is also an ACRP-CP (Association of Clinical Research Professionals-Certified Professional). She enjoys working out, volunteer work and spending time with her husband, son and friends.

• Association of Clinical Research Professionals (ACRP). Clinical Professional March 2024
• Basic Life Support. Expiration April 2026
• Fibroscan- Liver Scan Certification 2019
• Polymerase Chain Reaction (PCR) BioFire Machine Trained 2022
• Trained Vaccinator 2020
• Phlebotomy and Specimen Sample Processing Trained 2020
• Practical Process Improvement Ambassador
• Six Sigma Green Belt

• Therapeutic Units & Indications
• Neuroscience: Diabetic Peripheral Neuropathy Pain, Osteoarthritis Pain, Back Pain, Fibromyalgia, Migraine
• Vaccines: Covid 19, Respiratory Syncytial Virus, Flu, Marburg Virus, Ebola Virus
• Gastroenterology: IBS, Gastroparesis, Non-Alcoholic Steatohepatitis (NASH), Non-alcoholic Fatty Liver Disease (NAFLD), Non-Diabetic Weight Loss
• Endocrinology: Testosterone Replacement Therapy, Diabetic Weight Loss
• Immunology: Autoimmune Diseases
• Musculoskeletal: Gout
• Study Phases PH II, III, IV Studies
• Rating Scales Expertise: C-SSRS, Visual Analogue Scale, Patient Global Impression of Change, EQ-5D-5L, EQ-5D-3L, Brief Pain Inventory, Pain Catastrophizing Scale, Edmonton Frail Scale. Flu-PRO, SF12, PHQ-9, IWQOL-Lite-CT, SF-36V2: Acute.

• Institutional Review Board: Study Continuous Review, SAE submissions
• Institutional Biosafety Committee: Continuous Review, Facility Compliance

• Compliance with ICH, GLP, HAZMAT IATA requirements.
• Compliance with protocol specific laboratory requirements.
• Equipment certification and validation.
• Multiple Central Laboratories Interactions.
• CLIA Compliance.

• Neuroscience:
• A randomized double-blind, placebo-controlled study to assess the efficacy and safety of XXX in subjects with neuropathic pain associated with diabetic peripheral neuropathy.
• A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Low Back Pain, Osteoarthritis and Peripheral Neuropathy.
• A randomized double-blind, placebo-controlled study to assess the efficacy and safety of XXX in subjects with Fibromyalgia.
• A phase 3, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy, safety and tolerability of oral XXX for the prevention of migraine in participants with episodic migraine.
• Vaccines:
• A randomized, double-blind, placebo-controlled Phase 3 efficacy study of XXX vaccine in the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and older.
• A Parallel-group, Phase 3, multistage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines for prevention against COVID-19 in adults 18 years of age and older.
• A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of XXX, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in adults ≥ 60 Years of age.
• A Phase 3, randomized, placebo-controlled, observer-blind, multi-country study to demonstrate the efficacy of a single dose and annual revaccination doses of XXX investigational vaccine in adults aged 60 years and above.
• A Phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine with XXX adjuvant in adult participants >= 18 years with a pediatric expansion in adolescents (12 to < 18 years).
• A randomized, double-blind, placebo-controlled phase 3 study to assess the efficacy and safety of XXX for the prevention of SARS-CoV-2 mediated COVID-19 in adults aged 18 years and older.
• A Phase 3, open label, randomized, controlled, multi-country study to evaluate the immune response, safety and reactogenicity of XXX investigational vaccine when co-administered with Flu HD vaccine in adults aged 65 years and above.
• A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral Vectored Marburg Virus Vaccine in Healthy Adults.
• A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral Vectored Sudan Ebolavirus Vaccine in Healthy Adults.
• Gastroenterology:
• A double-blind, placebo-controlled, phase 2, response adaptive randomization study of XXX in patients with irritable bowel syndrome with diarrhea (IBS-D).
• A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of XXX in Patients with Diabetic Gastroparesis.
• A phase 3, multinational, double-blind, randomized, placebo-controlled study of XXX in patients with non-alcoholic steatohepatitis and fibrosis to resolve NASH and reduce progression to cirrhosis and/or hepatic decompensation.
• A 52-week, phase 3 study to evaluate safety and biomarkers of XXX in patients with non-alcoholic fatty liver disease (NAFLD).
• A randomized, double-blind, placebo-controlled phase 2 study comparing the efficacy and safety of XXX versus placebo in patients with non-alcoholic steatohepatitis (NASH).
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of XXX Tablets in Overweight/Obese Participants.
• Endocrinology:
• A phase 4, randomized, double-blind, placebo-controlled, multicenter study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with increased risk for cardiovascular (CV) disease.
• A research study to see how well XXX compared to XXX, XXX and placebo lowers blood sugar and body weight in people with type 2 diabetes treated with metformin with or without an SGLT2 inhibitor.
• Immunology:
• Human rheumatoid factor (RF) positive plasma for use in rheumatoid arthritis (RA) in diagnostic devices.
• Musculoskeletal:
• A randomized, multicenter, double-blind, double-dummy, parallel-group, placebo and active comparator-controlled, dose finding, and phase 2 study to assess efficacy and safety of XXX in gout patients with hyperuricemia.