
Clinical Research Associate
Work under the general mentorship of Staff Clinical Scientist or assigned Clinical Study lead for the project to prepare deliverables for the external validation activities for one or more assigned projects. Participate in the key phases of the external clinical study, including: planning, execution, analysis & close-out. This includes drafting the many vital documents for each phase. Perform planning phase activities such as literature search and product evidence strategy plan development, as well as study site qualification visits and reports. Support final study site selection, contract process and site initiation visits; participate in investigators meetings and other training of site personnel on the clinical study protocol, database, and investigator responsibilities. Ensure study site readiness, ship materials and investigational devices as needed, and track device accountability. Execute a clinical study monitoring plan, with interim and risk-based monitoring visits to verify site compliance to the study protocol and applicable regulations. Bring up protocol deviations and site compliance issues to the Clinical Staff Scientist or study lead, in accordance with clinical risk management and CAPA procedures.
Experience with clinical study management and monitoring for clinical diagnostics
Experience working with data management tools and understanding of databases and general statistical concepts
Ability to handle and resolve challenges and work under stressful conditions and in an environment of changing priorities
Documentation
Time Management
Design Control
Data management tools
Clinical study management.
Verbal communication
Detail Oriented
written communication
Multitasking Skills
Adatability
According to JobzMall, the average salary range for a Clinical Research Associate in Building 1, 1000 Lake Hazeltine Dr, Chaska, MN 55318, USA is $54,000 - $76,000. This range may vary depending on a number of factors, such as experience level, qualifications, and industry.
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Beckman Coulter Inc., is a Danaher Corporation company that develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing.

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