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Sterling Life Sciences, Specialists in Pharmaceuticals, Healthcare and BioTech Recruitment
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 Job #02481 Email this job to a friend
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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