Cardiac Dimensions, Inc.

Senior Clinical Research Associate

Cardiac Dimensions ®, Inc. (CDI) is an early stage, venture backed company developing a minimally invasive implantable product to treat mitral valve regurgitation associated with congestive heart failure (CHF). This percutaneous approach to annuloplasty is accomplished by implanting a device in the great cardiac vein/coronary sinus via a catheter-based delivery system. The implant is designed to reshape the mitral anulus and reduce mitral regurgitation.

Cardiac Dimensions is seeking a Senior Clinical Research Associate.

Key Responsibilities Include:

• Participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent Forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy and/or developing project-specific CRA training.
• Aid in the design and planning of CDI clinical trials, be assisting in the selection of investigational sites, investigators and study support personnel.
• Independently conduct pre-investigational site visits, Site Initiation Visits and subsequent monitoring visits, and Close-out visits.
• Build positive work relationships with the Investigators and study site personnel and other study support services (i.e., core laboratories, Clinical Events Committee, Data Safety Monitoring Boards, etc.).
• Obtain/maintain required study documentation for the Clinical Trial Master File.
• Review study data and investigator’s records for completeness, accuracy and consistency with study protocol.
• Ensure that CDI Investigators and clinical trial sites understand and adhere to the approved study plans and capture required information on the Case Report Forms and other study forms and document adherence to the study plan in the monitoring or other applicable reports.
• Assist in identification and implementation of enrollment strategies.
• Work with CDI Operations department to control shipment of investigational product and aid with accountability and documentation.
• Maintain CDI Investigational Study files.
• Train site support personnel on study plan and related procedures.
• Assist in the analysis of clinical and research data and assist in preparation of clinical reports or other technical papers.

Experience:

This position requires 5+ years experience (cardiac knowledge a plus). A strong clinical monitoring background and documentation skills in complex clinical trials preferred. Must have working knowledge of applicable regulations governing conduct of US and international regulations including but not limited to ISO and ICH regulations, 21CFR parts 50,54,56,812, and 814. Bachelor’s degree required. 5+ years relevant experience required, medical device experience preferred. Travel will be required 50% of the time (both domestic and international).

Cardiac Dimensions, Inc.

Email: hr@cardiacdimensions.com

Cardiac Dimensions, Inc. is an Equal Opportunity Employer

Submitted: 03/01/2006