Highly skilled Clinical Research Professional with 18 years of experience working with both Sponsors and CROs in pharmaceutical and medical device companies on Phase 1-4 studies. Expertise in reviewing, revising, and submitting study manuals, logs and plans; site monitoring/management. CRA and site training and evaluation, with a thorough knowledge of GCP and ICH guidelines. Adept liaison between the sponsor, site and CROs. Documented success in projecting, maintaining, and achieving study target timelines and data monitoring and integrity. Flexible and adaptable, a self-starter with a strong work ethic, very independent with the ability to foresee the needs of the study. Comfortable suggesting readjustments to tasks and workload flow to accomplish project timelines. Successfully conducted SQVs, SIVs, PMVs, IMVs and COVs. I enjoy what I do for a living. Ideally, I prefer working on Phase I studies, from start to finish, conducting the site monitoring visits, and supporting the study team is agreeable to my nature.Extensive experience with Microsoft Word, Excel, Outlook, and CTMS and EDC systems: Impact, Medidata, Medrio, Study Manager, Trail Master and IVRS.THERAPEUTIC SUMMARYPhase I: Healthy, hepatic, pharmacokinetic, drug abuse and drug dependencePhase II: Celiac Disease, Parkinson's diseasePhase III: Allergy, asthma, COPD, pre-term birth, psoriasis, constipation, Parkinson's disease, Class 3 Medical Device for aesthetic implantsPhase IV: Class 2 Medical device for orthopedicsTRAINING and EDUCATIONCITI: Human Subjects Research and Good Clinical Practice CertificationsSOCRA: Certified Clinical Research ProfessionalSAN DIEGO STATE UNIVERSITY, San Diego, CABachelor of Arts in Psychology: Deans List; Graduated Cum Laude with HonorsAll Graduate coursework completed for Master of Arts in Experimental Psychology, ABT (all but thesis)