Description

The Clinical Research Associate is an integral part of the Medical and Scientific Affairs and Clinical Operations function of BD Diagnostics, Preanalytical Systems located in Franklin Lakes, NJ.  This position has responsibility for developing, managing and reporting clinical trials to establish safety and efficacy of in vitro diagnostic and medical devices, to evaluate the effectiveness of Instructions For Use, to justify labeling and promotional claims, and to evaluate potential product defects or malfunctions.  Support of the products in the worldwide market by providing technical information, customer education, troubleshooting and identification of product improvements are also the responsibility of this position.  This position provides background, insight, counsel, and support from a base of clinical experience and knowledge to guide and implement device development, clinical testing, manufacturing, marketing, and post market surveillance. 
 
The position reports to the Worldwide Director, Clinical Operations. The CRA is responsible for multiple projects/studies and must work both independently and in a team environment in a rapidly changing organization.
 
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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