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Job #02414

About our client Our client is a publicly traded biopharmaceutical company headquartered in Massachusetts that is dedicated to the development and commercialization of therapeutics for CNS and pulmonary disorders. 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 Clinical Research Associate Massachusetts 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 3) Collect and file regulatory documentation interactions with CROs and other vendors 4) Ensure proper study closeout and documentation 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) Learn to identify, troubleshoot and resolve routine study conduct issues in-house and at the site, based on SOPs/GCPs 8) Ensure the proper collection, verification, and reporting of SAEs 9) Contribute to/participate in investigator meetings Requirements 1) Bachelor’s degree in a scientific discipline 2) 2+ years of clinical trial experience in the pharmaceutical or biotech industry 3) 2+ years of field monitoring 4) Experience in monitoring clinical trials from qualification to closeout 5) Exceptional communication skills 6) Strong knowledge and understanding of FDA Regulations and GCPs 7) Willingness to travel – up to 60-70%