Clinical Research Associate II
Job Requisition #: 11951
Date Posted: 11/30/2011
Category: Clinical
Location: Sunnyvale - CA - USA
About Us
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.
We are an Equal Opportunity/Affirmative Action Employer. The Cardiac Rhythm Management Division (CRMD) currently has the following position available:
Job Overview
Working under general supervision, applies clinical judgment to identify/resolve data discrepancies and implements corrections as needed. Is also accountable for analyzing and adjudicating adverse events from research sites, coordinating clinical data collection, analyzing technical data associated with clinical protocol testing and/or post market surveillance studies, assists in the proper reporting of study results. In addition, ensures appropriate monitoring of designated clinical trials for St. Jude Medical CRMD is occurring for completeness and accuracy of data as well as compliance with U.S. Food & Drug Administration (FDA) or other Regulatory body regulations.
Requirements/Education: A Bachelor of Arts/Bachelor of Science degree in natural science, pre-medicine, nursing, engineering, a related academic field, or equivalent related work experience. Additionally, a minimum of two plus years of related work experience as a Clinical Research Associate or equivalent (e.g., Research Coordinator) experience which should include (but is 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. Must be able to demonstrate and use discretion in exercising work assignments and handle sensitive/confidential information in an effective manner. Must have the demonstrated ability to understand and comply with applicable government regulations and Company operating procedures, processes, policies, and tasks. Must have demonstrated personal computer skills including a working familiarity with word processing software and relevant clinical applications. The ability to concentrate on detail and work independently is also required.
Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation, such as Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). Previous related experience in a medical device, biologics, or pharmaceutical company. Previous industry experience with Class III medical devices is a plus. A general familiarity with cardiac rhythm management technology, such as pacemakers, and with the clinical trial process is preferred.
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