FATIMA MENENDEZ

Clinical Research Coordinator with 3 years of experience managing and coordinating phase II, III, and IV clinical trials specifically in Pediatric Neurology. Proven expertise in ensuring protocol adherence, maintaining data integrity, and upholding standard practice compliance. Skills include patient recruitment, study start-up and close-out processes, and navigating electronic data collection systems. Ability to streamline collaborative relationships with sponsors, primary investigators, and clinical research specialists. Committed to advancing clinical research through meticulous oversight and proactive problem-solving.

· IATA Transporting Dangerous Goods, Mayo Clinic

· Columbia Suicide Severity Rating Scale (C-SSRS)

· CITI Good Clinical Practice (GCP) Certificate

· CITI Human Subject Biomedical Certificate

· RBT Certified

• STUDY COORDINATOR: A 2-YEAR RANDOMIZED, 3-ARM, DOUBLE-BLIND, NON-INFERIORITY STUDY COMPARING THE EFFICACY AND SAFETY OF XXX AND XXX VERSUS XXX IN PEDIATRIC PATIENTS WITH MULTIPLE SCLEROSIS FOLLOWED BY AN OPEN-LABEL EXTENSION
• STUDY COORDINATOR: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 1B STUDY WITH OPEN-LABEL EXTENSION TO ASSESS THE SAFETY, TOLERABILITY, AND PRELIMINARY EFFICACY OF XXX IN PEDIATRIC MALE PATIENTS WITH DUCHENNE MUSCULAR DYSTROPHY (DMD)
• STUDY COORDINATOR: INVESTIGATION OF ENDOCRINE BIOMARKERS IN PEDIATRIC-ONSET MULTIPLE SCLEROSIS
• STUDY COORDINATOR: PROGNOSIS, TREATMENT, AND MECHANISMS IN AN INTERNATIONAL PEDIATRIC ONSET OPSOCLONUS MYOCLONUS ATAXIA SYNDROME (POOMAS) DATABASE AND VIRTUAL BIOBANK
• STUDY COORDINATOR: AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF XXX IN PEDIATRIC PATIENTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS
• STUDY COORDINATOR: MUSCULAR DYSTROPHY ASSOCIATION NEUROMUSCULAR OBSERVATIONAL RESEARCH (MOVR) DATA HUB PROTOCOL # MDACS1
• STUDY COORDINATOR: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY, EFFICACY, AND PHARMACODYNAMICS OF 52 WEEKS OF TREATMENT WITH XXX IN CHILDREN WITH DUP15Q SYNDROME
• STUDY COORDINATOR: AN OPEN-LABEL UNCONTROLLED MULTICENTER STUDY TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND ACTIVITY OF XXX IN CHILDREN AGED 2 TO LESS THAN 18 YEARS WITH GENERALIZED MYASTHENIA GRAVIS.