Clinical Research Associate III

DescriptionBiosense Webster, a member of Johnson & Johnson's Family of Companies, is recruiting for a Clinical Research Associate III, located in Diamond Bar CA. Biosense Webster, Inc. is recognized worldwide as an industry leader in endocardial diagnostics and therapy. Guided by the needs of electrophysiologists and cardiologists, the company has pioneered innovative technological advancements ranging from the first deflectable tip catheter to today's most sophisticated three-dimensional cardiac mapping and navigation systems. Biosense Webster, Inc., combines leading-edge technology with a tradition of quality and responsiveness while partnering with the physician to optimize patient outcomes. The CRA III will be responsible for defining study protocols, conducting clinical research trials. Ability to ensure the efficacy and safety of company products by performing the following essential duties. In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson and Biosense Webster procedures and guidelines, this position: Under minimal supervision, individual designs, supervises and develops clinical trial strategies. Proactively manages clinical projects as well as develops protocols and case report forms.Experience working with and managing various aspects managed by Contract Research Organizations (CROs)Assists in preparation of regulatory submissions to FDA.Interfaces with internal and external customers.Interfaces with marketing, regulatory affairs and research project teams to provide technical consultation as appropriate.Develops practicable solutions to a wide variety of difficult problems.Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.Responsible for communicating business related issues or opportunities to next management level.Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.Performs other duties assigned as needed. QualificationsA minimum of a Bachelor's degree is required with a minimum of 4 years of clinical research experience, or an Advanced degree is required with 2 or more years of clinical research experience.Prior CRO management and/or managing multiple vendors is preferred.Medical Device experience is preferred.Thorough understanding of Good Clinical Practices (GCP) is required.Ability to use PC and associated software, excellent PowerPoint, Word, Excel skills and Good written and oral (English) communication skills is required.Must be able to travel (global and domestic) overnight as needed or requested.BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.