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| Job #02481 |
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| About our client |
| Our client is a publicly traded biopharmaceutical company that is dedicated to the development and commercialization of monoclonal antibody therapies for treatment of cancer. The company has an experienced management team, marketed products and a robust pipeline. |
| Position |
Location |
| Regional Clinical Research Associate (Home-Based) |
Washington |
| 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) Contribute to/participate in investigator meetings 4) Ensure timely data basing of CRFs and routing/resolution of all data queries 5) Identify, troubleshoot and resolve routine study conduct issues in-house and at the site, based on SOPs/GCPs 6) Ensure the proper collection, verification, and reporting of SAEs 7) Assist in the development of CRFs, CRF completion guidelines and other relevant study manuals/materials 8) Ensure proper study closeout and documentation |
| Requirements |
1) Bachelor's degree in a scientific discipline 2) 2+ years of clinical trial experience in the pharmaceutical or biotech industry (field monitoring) 3) Extensive experience in oncology trials 4) Experience in monitoring clinical studies from qualification to closeout 5) Strong knowledge and understanding of FDA regulations and GCPs 6) Exceptional communication skills 7) Willingness to travel – up to 70% (overnight) |

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