US-NJ-Franklin Lakes: Clinical Research Associate in biotech

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Date: 16-Dec-2008

Clinical Research Associate in biotech

The Clinical Research Associate will be responsible for the following:

* In conjunction with the project teams develop clinical study programs to support development, regulatory agency clearance, and marketing of new or modified products. * Manage the budget and timelines of the clinical studies and activities to support key project deliverables. * Author/CoAuthor study protocols, develop study documents, identify and enlist clinical sites, ensure availability of all clinical trial materials, facilitate IRB approval, train investigators and their staff on the study procedures, oversee and monitor trials, maintain contact information, manage data and query resolution, ensure appropriate data analysis and write the final report. * Ensure the adequacy of all study documentation, establish and maintain the central study file. Contribute to publications based upon clinical studies for which they are responsible. * Perform all studies in compliance with Good Laboratory Practices, Good Clinical Practices, and all national, international and local Regulations. * Remain knowledgeable about current evolving regulations and guidelines concerning medical devices and clinical trials in general. * Remain current in their field of expertise by study of technical literature, attendance at continuing education sources, and symposia, product expositions, and customer visits. * Travel up to 25% of the time as required.

Qualifications Knowledge and Skills:

* Demonstrated experience in working on cross functional teams * Excellent verbal and written communication skills * Good working knowledge of study design, statistics and data analysis * Working knowledge of Good Clinical Practices, human subject protection regulations, and clinical research * Working knowledge and/or experience with clinical laboratory instrumentation and in vitro diagnostic and medical devices and clinical diagnostic tests * Experience with regulatory filings (510(k), PMA, or IDE) desirable * Strong computer skills (MS Office, including Word, Excel, Access, PowerPoint, Project)

Education and Experience:

* BS in health-related field, MS in health related field highly desirable * CRA certification desired and MT(ASCP) certification a plus * 3-5 years experience in clinical trial experience. * 1-3 years clinical laboratory science highly desired * Equivalent education or experience will be considered.

To apply for this position, please visit this Website.

Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/