[Employment] US-NJ-Franklin Lakes: Clinical Research Associate in biotech

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US-NJ-Franklin Lakes: Clinical Research Associate in biotech
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http://biotech.fyicenter.com/jobs/99894030_Clinical_Research_Associate__in_biotech.html
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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.



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