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Job #02310

About our client Our client is a development-stage medical device company focused on providing mechanical means for the treatment of heart failure. Founded in the late '90s, the company has entered early human trials with its initial device and intends to pursue a family of products to expand the capabilities and applicability of its product platform. Position Location Clinical Research Associate California Salary Highly competitive package, commensurate with experience Responsibilities 1) Perform clinical trial activities related to study initiation and data acquisition, including case report form verification 2) Review adverse events 3) Compile source documents and monitor site 4) Review clinical data for completeness and accuracy 5) Identify discrepancies and work with field or site personnel to resolve issues 6) Acquire and compile source documents for adverse events for presentation to Clinical Events Committee 7) Assist with preparation of reports for the Data Safety Monitoring Board 8) Coordinate investigator and other meetings 9) Assist in the collection and preparation of data for publications 10) Ensure site compliance to study protocols, good clinical practices and FDA requirements for clinical trials 11) Recognize problems, recommend and implement methods to improve conduct of the clinical study 12) Assist in development of protocols, case report forms and other documentation necessary to initiate new trials 13) Perform other duties as assigned Requirements 1) BS degree in Life Sciences, technical discipline (Nursing a real plus) 2) 5-8 years of experience in medical device clinical trial (cardiac and/or cardiology preferred) 3) Experience in working with government agencies and investigators to support approval for commercial distribution of medical devices 4) Ability to understand both technical and clinical aspects of product and procedure 5) Strong project management abilities 6) Ability to build good relationships with clinicians and support personnel 7) Excellent written and verbal communication skills, 8) Computer literacy 9) Willingness to travel – up to 15% (to sites to monitor and collect data, including international travel)