Description
Job Description: Working with limited direction, is responsible for assisting in the coordination of clinical data collection, researching and analyzing technical data associated with clinical protocol testing and/or post market surveillance studies, and ensuring that site administration paper work is both complete and current. In addition, this position ensures appropriate monitoring of designated clinical trials for completeness and accuracy of data as well as compliance with U.S. Food & Drug Administration (FDA) or other Regulatory body regulations. Coordinates the initiation of the clinical site, conducting clinical site audits, identifying and obtaining missing data and data corrections, maintaining accurate, detailed and complete records of audits and assisting in the reporting of study results. Applies theoretical principles and analytical techniques normally acquired in a recognized four-year course of study. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness.Requirements/Education: A Bachelor of Science degree in natural science, pre-medicine, nursing, engineering, a related academic field. Additionally, a minimum of 3 years of experience as a Clinical Research Associate or equivalent experience which could include (but not limited to): clinical research of drugs or medical devices, non-cardiovascular medical device experience, etc.). Must have demonstrated written and verbal communication, interpersonal, presentation, analytical, organizational skills, the ability to interpret clinical data, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Comprehensive personal computer skills including experience with word processing software and relevant clinical applications. The ability to concentrate on detail and work independently. Must be able to maintain regular and predictable attendance.
Desired Requirements: An advanced credential in a relevant discipline/concentration. Previous related experience in a medical device, biologics, or pharmaceutical company. Previous industry experience with Class III medical devices is a plus. A familiarity with cardiac rhythm management technology, such as pacemakers, Heart Rhythm Society Heart Rhythm Society Certification in Electrophysiology (EP) and Implantable Cardioverter-Defibrillator (ICD)/Pacing or an equivalent certification of expertise, and with the clinical trial process is preferred.
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