I have 25 years of experience in the clinical research industry as a professional registered nurse, site coordinator, CRA, of both human and animal studies. Ensuring study conduct per sponsor SOPs and ICH/GCP guidelines, protection of subject safety/rights through proper trial conduct and IRB/IEC relations, serious adverse event (SAE) reporting, management of trials via CTMS/EDC/IVRS/IWRS and other proprietary systems, accountability of investigational products, mentorship/education of junior-level colleagues/site-level health-care professionals regarding clinical trial developments, protocol amendments and program administration.I am open to all therapeutic areas with expertise in all Phases I have experience in Respiratory and Endocrinology, Rheumatology, Cardiology, Woman's Health, Musculoskeletal and Nervous System and Oncology with Animal health. As a professional registered nurse, I have experience with Neonatal and Adult care in most therapeutic areas as well as Animal Health in the Veterinary practice.
Listed skills include Clinical Research, Quality Assurance, Team Building, Data Analysis, and 21 others.