Crystal Poniente Email & Phone Number

San Diego, Ca, Us

San Diego, California, United States

San Diego

• water wise landscape design/installation• custom botanical arrangements in re-purposed electronics/appliances and vintage planters • vertical planters/living walls• terrariums• tabletop desert gardens• creative collaborations• workshops• event design and styling• event centerpieces and arrangements

• Development and maintenance of a central filing system to ensure, complete, accurate and current files of regulatory documents and study records.• Maintain and track study site clinical supplies (drug, devices, etc.) and associated documentation• Preparation and implementation of investigator meetings• Develop and maintain communication with internal and external departments/offices• Responsible for the production of clinical meeting agendas and meeting minutes• Set up new studies in Clindex Clinical Trial Management System (CTMS) and track regulatory documents, CRFs and data queries using Clindex.• Assist CRAs in preparing for study closeout by conducting TMF reviews and compiling closeout binders.• Archive TMF and related project files for completed studies.• Complete pre-entry CRF review and perform first or second pass data entry• Database validation execution• Development and review of Standard Operating Procedures (SOPs) and Clinical Department Internal Guidances• Thorough knowledge of GCPs, ICH and other regulatory guidelines.• Tracking, filing and distribution of weekly updates of subject enrollment logs from the study sites

• Provide communication to Clinical Research Associates, Principal Investigators, clinical suppliers, clinical laboratories, Clinical Project Managers and team members concerning the status of various regulatory and clinical documents.• Keep the Clinical Project Managers and Clinical Research Associates fully apprised of site and study status, especially during study start-up, but also throughout the course of the study.• Sets up CTMS for new studies.• Maintains CTMS to allow tracking of study status and enrollment; ensures document tracking is updated and current throughout the study.• Serve as liaison with sites to complete all pre-study requirements.• Responsible for the preparation and maintenance of the Site Regulatory Binder and site reference tools.• Responsible for the ordering, distribution and maintenance of study-specific supplies. • Assures compliance with Good Clinical Practices (GCP) of FDA/ICH related to essential (regulatory) documents.• Ensures completion of regulatory documents prior to final review/approval and coordinates shipment of site initiation materials and supplies.• Ensures regulatory documents are available and current throughout the course of the study.• Provides identification of missing regulatory documents to Clinical Project Managers and Clinical Research Associates.• Assists Clinical Research Assistants in preparing for study closeout by completing pre-closeout visit file reviews to determine the documents that are present and /or needed in the site files. Complete the preparation /shipment of the closeout visit binder and the applicable documents needed for the Clinical Research Assistant to complete the visit.• Assists with the preparation and coordination of Launch Meetings.• Assists with the preparation and coordination of Investigator Meetings.• Provides oversight of the Clinical Administrative group and works closely with the Director of Clinical Operations to ensure studies are adequately supported.