Clinical Research Associate II 1 of 2 positions Job
Johnson & Johnson
Job Code - 60006
Position - See job description
Job First Active on: Monday, April 16, 2012
Clinical Research Associate II (1 of 2 positions)
Mentor Corporation, a member of the J&J Family of Companies, is actively recruiting for 2 openings for Clinical Research Associate II, located in Santa Barbara, CA
Mentor is a trusted global leader in aesthetic medicine among both consumers and clinicians by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life. The company has products and services in three areas of aesthetics: breast (augmentation and reconstruction), body and face.
The Clinical Research Associate II will design, plan and conduct clinical research trials by effectively coordinating the activities of study coordinators and investigators and by ensuring compliance with study protocols, FDA regulations, IRB requirements, and overall clinical objectives. May review clinical data. Assist in the implementation of departmental/organizational goals and objectives.
MAJOR DUTIES & RESPONSIBILITES:
Under review of CPD management, plan design, and implement CPD projects. Oversee patient screening and enrollment at assigned clinical study sites. Monitor ongoing compliance to study protocols. Ensure adherence to FDA and IRB requirements. Work with investigators to quickly and effectively resolve discrepancies in data gathering process or regulatory procedures. Review source documentation, case report forms, and data reports for accuracy. Ensure timely submission of case report forms. Coordinate meetings with site coordinators and investigators. Identify and prepare written reports for serious or unexpected adverse events. Ensure accurate inventory of clinical study product. Prepare accurate and timely reports to CPD management. Support company goals and objectives, policies and procedures, good clinical practices, and FDA regulations.
REQUIREMENTS - QUALIFICATIONS: Clinical Research Associate II (1 of 2 positions)
A minimum of a Bachelor's degree is required. The qualified candidate must have either 2 or more years of experience as a Clinical Research Associate (or relative titled role/responsibilities) within the industry (Pharma, Medical Device, Biotech, CRO, Clinical Site, etc) OR if 1 year of experience as a Clinical Research Associate, must have additional years of relevant experience in clinical research, research & development or health-related field, in addition to working knowledge of FDA regulatory regulation.Strong basic understanding of scientific principals and FDA regulations required. Must possess excellent written and verbal communication skills. Ability to interact and work with other departmental personnel, and work as a contributing team member. Strong analytical skills and extremely strong organizational skills. Familiarization with office software, including Microsoft Word, Excel, Outlook. Ability to use the Internet to perform basic research. Position typically requires travel 40% of time, but depending on projects, travel may be significantly more or less. BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Johnson & Johnson
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