provides expertise in a variety of areas. She is certified as a clinical research auditor and performs research department compliance risk assessments and GCP clinical trial audits. She has more than 30 years of clinical nursing experience and acquired clinical research skills during her work with world-renown investigators at Baylor College of Medicine and Houston Methodist Research Institute. She developed proficiencies in regulatory operations and compliance, research project coordination, coverage analysis, budget development, and negotiations. She graduated from Texas Woman’s University in the Texas Medical Center in Houston, Texas. She is a member of ACRP, ANA and TNA and is certified as a clinical research coordinator with the Association of Clinical Research Professionals.
· Site audits of either the entire research department or of specific trials;
· Process assessment and risk analysis;
· Development and conduction of research team training;
· Regulatory assessment;
· Study coordination services;
· Document concordance review;
· Clinical Trials Office document development such as policies and standard operating procedures, forms, templates, manuals and job descriptions and develop staff training for same;
· Coverage analysis;
· Compliance project customized with your needs.