El Segundo, CA30+ days ago
Collect study and site metrics and maintain study trackers, as needed • Conduct case report form (CRF) data review and review of source documents, work with sites to resolve data queries • Communicate regularly with field Clinical Research Associates (CRAs) to provide information before and after site visits • Partner with field CRAs and CTAs to resolve issues identified during site visits • Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) to properly conduct the trial as well as resolve IP temperature monitoring excursions and train or assist sites with corrective actions • Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues • Conduct clinical specimen log review, and coordinate shipment of specimens to the sponsor or contracted vendor • Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted vendors • Conduct remote monitoring tasks including reconciliation of site investigational product accountability • Provide data listings and compile clinical study report documents to support medical writing activities • Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations • Provide support and escalate issues to the Clinical Trial Manager (CTM) as appropriate. Knowledge, Skills, & Abilities • Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe • Excellent written/oral communication skills • Strong organizational and multi-tasking skills • Maintain corporate confidentiality at all times • Ability to set priorities and independent decision making • Ability to work independently as well as in teams • Strong oral and written communication skills • Outgoing and confident demeanor • Independent thinker and persuasive communicator • Detail oriented, with solid organization and time management skills • Completes projects with reliability and minimal guidance • Knowledge of drug development process • Computer literacy: EDC, eTMF, CTMS, etc.