Clinical Research Assistant

Clinical Research Assistant will perform work in one or all of the following areas Phlebotomy, Data Entry, and Administrative Assistant responsibilities in support of the clinical research team. The Clinical Research Assistant will assist in the management of multiple clinical trials according to the study protocol, perform collection of clinical data points, and provide seamless customer service to the patients attending the site.Responsibilities Include but not limited to:Complete training and ensure adherence of GCPs, SOPs, IATA, and HIPPAEnsure compliance with all clinical trial protocolsEnsure compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC, and HIPPA.Assist research staff with Phase II-IV clinical trials from start through closureEnter visits, patient recruitment in Real Time Clinical Trial Management System (CTMS)Aid research department is meeting contracted and expected recruitment goalsEngage in quality assurance of all study documents and data prior to monitoring visitsSupport central and local marketing campaigns by entering recruitment data, contacting patients and scheduling.Coordinate office visits for trial participants based on the protocolPerform phlebotomy, collect, process and ship clinical specimensAssist in patient care visits and procedures according to protocolReceive medication, confirm temperature in range and maintain temperature logsPerform ECGsEngage in patient recruitmentAssist with entry into Electronic Data Capture (EDC) data queries are resolvedParticipate in Investigator meetings and trainings during the course of the trialGenerate PowerPoint presentationsCreate and organize new patient charts, lab and other required supplies prior to the patient visit.Gain access to Institutional Review Boards.Maintain regulatory binders, CRFs, subject charting, and source documentsMaintain the Investigator Site FilesAssist with keeping Institutional Review Boards (IRB) documents, Electronic Data Capture (EDC) Clinical Trials Management System (CTMS) and Interactive Web Response Systems (IWRS) currentWill support central and local marketing campaigns by contacting potential subjects and schedulingPossess a minimum of two (2) years experience in the clinical research or closely related fieldBachelors degree or relevant work experience.Bilingual (Spanish), a plus. #J-18808-Ljbffr Dermcare Management Llc