Support the investigator evaluation and recruitment process: o Create phone scripts, questionnaires, and other assessment tools for use in the selection of sites; o Assist team in the development of site recruitment and retention strategy; o Initiate contact with PIs, conduct pre-visits, assess potential investigators and recommend suitability of the site; Assist clinical team with study start-up activities: o Assist in development of protocol / ICF / CRF / CRF completion guidelines, preparation and maintenance of monitoring plans, study binders, study manuals, and other site specific and monitoring tools; o Requests and collects initial regulatory documentation; o Ensure that sites fulfill their regulatory obligations and submit study documents for IRB review and approval; o Performs study tracking and advises PM when an investigational site is approved and ready to receive investigational device supplies; Site Management and study execution activities: o Plan and conduct training / site initiation, interim and close-out visits. Thorough understanding of operational aspects of clinical research and regulatory regulations; Good interpersonal, problem solving and communication skills; Excellent follow-through capability; Self-motivated, attention to detail and organizational skill; Experience with various computer systems / applications and clinical trial management systems; willingness to learn new systems / databases as needed.