SONUS Pharmaceuticals, Inc.

Clinical Research Associate III

REPORTS TO: Director, Clinical Operations

1. PURPOSE:

With direction from management, participates in the designs, planning and implementation of the overall direction of clinical research projects. Coordinates activities of internal and external study team members to ensure compliance with protocol, internal standards and all applicable regulatory requirements. Works on complex problems in which analysis of situations or data requires an in depth evaluation of various factors. Exercises judgment within broadly practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

2. MAJOR DUTIES and RESPONSIBILITIES:
• With direction from study manager or Clinical Operations Director participates in the preparation of clinical trial protocol, amendments, related study materials (e.g. study manual, CRFs) with attention to providing documents that provide accurate and complete information and instruction that ensures compliance with applicable regulations and guidance, and provide complete and interpretable data that will achieve the study’s objectives.
• Work directly with assigned Investigators, clinical trial vendors (CTVs), and contract research organization (CROs) to manage study implementation, study conduct and closeout activities including monitoring, reporting and communication activities.
• Manages interactions with assigned CTVs/CROs including assisting with qualification and selection, contract negotiation, ongoing budget management and forecasring.
• Monitors and reports on adherence of Sonus staff and CTVs/CROs to Sonus Clinical SOPs and requirements of U.S. FDA and other applicable national regulations and guidelines for the conduct of clinical research.
• Complies and provides information and reports to supervisor/management on trial related activities that identifies emerging issues and provides strategies to manage.
3. LEVEL REQUIREMENTS:

Experienced position requiring a high-level of performance, often with little supervision. May also provide leadership to other clinical research staff. Requires a Bachelors/Masters degree, with a minimum of 5 of clinical trials conduct experience.

Requires ability to organize complex projects and track large volumes of information; assess performance and identify early warning signs; provde and implement strategies for improvement.

Requires facility with MS Word, Excel, Outlook. Experience with MS Project desirable. Requires ability to travel as required (anticipated approximately 20%).

SONUS Pharmaceuticals, Inc.

Email: careers@sonuspharma.com

SONUS Pharmaceuticals, Inc. is an Equal Opportunity Employer

Submitted: 03/13/2006