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WHAT
IN
Clinical Research Associate II in-house
Job
Johnson & Johnson
US
-
,
California
Job Code - 13766
Position - See job description
Job First Active on: Tuesday, October 20, 2009
APPLY TO THIS JOB (You will be applying directly to Johnson & Johnson for this position!)
JOB DESCRIPTION: Clinical Research Associate II (in-house)
Location: Santa Barbara, CA
The Mentor Corporation division is a global leader in aesthetics. Mentor Corporation enjoys a reputation for developing the highest quality surgical and non-surgical products to enhance the lives of patients and for providing outstanding service to its healthcare customers.
The Clinical Research Associate II will be responsible for: Requiring minimal supervision, implement clinical studies and projects. Travel approximately 50% to Investigational sites. Conduct initiation, interim, and close-out monitoring visits. Study management, including protocol and CRF development, FDA submissions and responses, annual report review and contribution. Assist with budget responsibilities. Monitor trial progress with the site research staff. Training new CRAs. Present data at Investigator meetings. Oversee patient screening and enrollment at assigned clinical study sites. Ensure site compliance to study protocols and adherence to FDA and IRB requirements. Ensure timely submission of case report forms. Review source documentation, case report forms and data reports for accuracy. Coordinate meetings with site coordinator and investigator(s). Conduct reconciliations to ensure device accountability. Provide project status reports to management. Support company goals and objectives, policies and procedures, good clinical practices ad FDA regulations. Participate in direct office contact. Conduct office follow-up activities: investigator enrollment, IRB approvals, patient enrollment, and obtain missing forms and issues corrective action plan follow-ups. Perform reconciliation office calls. Perform patient filer review and maintenance. Administer site report actions and communication: accountability and missing forms.
REQUIREMENTS - QUALIFICATIONS: Clinical Research Associate II (in-house)
A minimum of 3 years related Clinical Research Associate experience at medical device or pharmaceutical company required. A minimum of a Bachelors degree is required, preferably in a related field. Clinical Research Associate certification is preferred. Must possess excellent written and verbal skills. Must possess working knowledge of medical terminology and clinical research applications. Ability to interact and work with other departmental personnel and work as a contributing team member. Must be detail-oriented with strong organizational skills. Must have strong basic understanding of research methodology and FDA regulations. Must be able to work independently. Must be innovative, creative and flexible and able to effectively identify and resolve problems. Familiar with MS Office, including Word, Access, Excel and Outlook. Ability to use internet to perform basic research. 40-50% travel is required.
Johnson & Johnson
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