Clinical Research Specialist

Job Description: Designs and writes detailed training materials Designs and writes investigational clinical trial research protocols detailing study procedures, hypotheses, and aims Assesses design constraints at an early stage of the project for presentation to management Stays current with product capabilities and industry to advise the organization regarding important scientific developments Interacts with groups to ensure Stago is at the forefront of the market's evolution Collaborates on development of study protocols, data collection tools, lab manuals, case reports, and databases with French counterparts Leads field evaluations for potential study sites Communicate and train NCRA’s on the protocol and supports the NCRA with the execution of the study to all external stakeholders Keeps current with FDA and CLSI regulations that impact coagulation and hematology Responsible for the development of study related documents Assist in the development and monitoring of the study budget and study cadence Responsible for review and statistical analysis of the data Requirements: B.S. in R&D Engineering / Biomedical Engineering or Medical Technology/Clinical Laboratory Science or equivalent from an accredited four-year college or university required MT(ASCP) Certification or equivalent required Minimum five years hospital experience in Hematology and Coagulation preferably experienced with validations, correlations and training lab staff on new laboratory instrumentation Experience in project management, designing, organizing, and conducting clinical trials Demonstrated competency in the statistical review and analysis of clinical data Experience in IVD product development is preferred Applications, Minitab, Analyze-it or other statistical software and other company software Benefits: Reasonable accommodations for individuals with disabilities COVID-19 vaccination required for employees Competitive salary and benefits package available #J-18808-Ljbffr