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Job #02502

About our client Our client is a privately owned medical device company that is focused on the treatment of CNS disorders. The company has an experienced CEO and board, an exciting product candidate and a team that is committed to the highest standards of integrity and to improving the lives of patients and their families. Position Location Senior Clinical Research Associate East Coast, USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Identify, recruit and evaluate investigators 2) Execute routine clinical study assignments, including study initiation, training of centers, study site and in-house data monitoring, etc. 3) Ensure collection and filing of regulatory documentation 4) Interact with CROs and other vendors 5) Assist in the development of CRFs, CRF completion guidelines and other relevant study manuals/materials 6) Ensure timely data basing of CRFs and routing/resolution of all data queries 7) Contribute to/participate in investigator meetings 8) Ensure proper collection, verification and reporting of SAEs 9) Learn to identify, troubleshoot and resolve routine study conduct issues in-house and at the site, based on SOPs/GCPs 10) Ensure proper study closeout and documentation Requirements 1) RN 2) 4+ years of clinical trial experience in the pharmaceutical or biotech industry 3) Experience in monitoring clinical studies from qualification to closeout 4) Device or CNS (stroke) experience (preferred) 5) Strong knowledge and understanding of FDA regulations and GCPs 6) Exceptional communication skills 7) Willingness to travel – up to 75% (overnight)