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Job #02844

About our client Our client is a reputable, mid-size CRO that is experiencing unprecedented growth and is headquartered in Newton, MA. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Senior Clinical Research Associate Newton, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Conduct study qualification, initiation, interim monitoring and closeout visits of assigned clinical sites 2) Maintain close communication with clinical sites to ensure adherence to protocol and regulatory guidelines, maximize study enrollment as well as resolve problems 3) Monitor queries generated by the Data Management Team 4) Complete clinical site monitoring as per established guidelines 5) Review CRFs for clarity and consistency with source documents 6) Ensure accuracy of study test article inventory records 7) Review and ensure maintenance of site regulatory files 8) Complete and submit monitoring reports 9) Manage performance problems and provide re-training to clinical sites (as necessary) 10) Participate in client meetings (as necessary) 11) Maintain an understanding of current monitoring practices and applicable regulatory requirements and guidelines 12) Provide leadership to CRA Team for specific studies by developing the monitoring plan, serving as Lead CRA 13) Participate in protocol review and CRF development 14) Mentor new hires and the junior CRA staff Requirements 1) RN and BSN preferred or a Bachelor’s degree in Math, Science or a related field (Master’s degree in a related field preferred) 2) 3 – 5 years of experience in clinical site monitoring 3) Pharmaceutical trial experience preferred 4) In-depth understanding of medical terminology 5) Excellent organizational skills 6) Self-motivated and flexible 7) Proficiency in MS Word, PowerPoint and Excel 8) Good communication skills (written and verbal) 9) Willingness to travel – up to 60%