Liz Ryan Elizabeth Homsher Smith

About Liz Ryan Elizabeth Homsher Smith

Recently “retired”, as I’m blessed to be a Stay-at-home Mommy. Plan on doing so for the foreseeable future. I am a versatile Clinical Research Professional with over 13 years of experience in the clinical research industry. I\'ve worked on both investigational drug and device studies. My clinical research therapeutic areas include: Ortho/Neuro Spine, Rheumatology, Hematology, Women\'s Health, Psychology, RLS, MS, Cardiology, Infectious Disease, Respiratory, Pulmonary, and Exercise Physiology.Specialties include: All aspects of clinical monitoring, site management, and feasibility/study start-up to study closure of Phase I through Phase IV clinical trials. I am currently working as a contract employee for a CRO in Carlsbad, CA as a Clinical Research Associate (CRA). My experience includes CRA, COA (Clinical Operations Associate), CTS (Clinical Trial Specialist) and Lead CRC (Clinical Research Coordinator). I have been a Certified Clinical Research Professional (CCRP) with the Society of Clinical Research Associates organization (SoCRA) since 2005. Skills:Study Start Up and FeasibilityBudgets / Contracts / CDAsMonitoring (PSVs, SIVs, IMVs, COVs)Investigator Meeting planningTMF set up and maintenanceSurvey Monkey Extensive Excel tracker creation and maintenanceDatabase entry / EDC / CTMSDrug / Device AccountabilityCSR anaylsisTLGsDXA scanning (Lunar DPX and Hologic Delphi W)ECG\'s and VitalsExercise PrescriptionPatient BillingWeight and Stress ManagementHydrostatic WeighingBody Fat AnalysisSkin Fold TestingLight Phlebotomy

Experience

1. Clinical Research Associate Ii

   Synteract

   Jul 2014 — Present · Carlsbad, CA, US

   Interfaces with sponsor representatives & study team to ensure timely initiation & completion of clinical trials; Responsible for the identification, evaluation & qualification of PIs/sites; Prepares initial Reg Doc packages; Collects/reviews Reg Docs received from clinical sites to ensure all required documents are obtained, complete & in compliance with GCP & local regulations; May assist with the preparation, review & submission of all relevant Reg Doc\'s to the appropriate Regulatory Authorities & IRB/IECs; Maintains TMF & ISFs for the duration of the study, ensuring essential documents are filed appropriately, & assisting in the file review & reconciliation process in preparation for audits & archival; Maintains & updates project-related data in an existing database; Reviews ICFs and/or data protection authorizations as required; Performs on-site monitoring of clinical studies through review of CRFs & study records in order to report trends in safety, ensure timely reporting of AEs & compliance with protocols, local regulations, ICH-GCP & SOPs; Documents monitoring activities in monitoring reports & follow-up letters; Responsibile for communicating directly with sites to provide study direction, answer questions, assess study recruitment rates & respond to sponsor requests; Monitors & reports study progress/status on a site level; Assists with processing of clinical investigator payments, study expense reports & other financial items; Prepares or contributes to study related correspondence, meeting minutes, tracking spreadsheets & the preparation of presentations; Assists in the planning, organizing & executing of project-specific meetings; Prepares sites for audit by sponsor or inspections by FDA or other Competent Authorities; participates in internal audit preparation; assists with audit responses; Performs training of site personnel.

Education

• Colorado State University

  BS

Skills

• Pharmaceutical Industry
• Virology
• Budgets
• Trip Report Review
• Cardiology
• Women's Health
• Ich-Gcp
• Patient Recruitment
• Als
• Multiple Sclerosis
• Crfs
• Clinical Research Associates
• Crf Design
• Clinical Data Management
• Clinical Monitoring
• Regulatory Submissions
• Clinical Trials
• Meeting Planning
• Rheumatology
• Clinical Study Design
• Lupus
• Rheumatoid Arthritis
• Irb
• CRO
• Cdc Surveillance
• Tmf
• Newsletters
• Work Instructions/Sops
• Clinical Development
• Clinical Research Experience
• Spine
• Source Documents
• Protocol
• Exercise Physiology
• Regulatory Affairs
• Influenza
• Survey Monkey
• Edc
• Therapeutic Areas
• Ctms