Calypso® Medical Technologies, Inc.

Clinical Research Associate

At Calypso® Medical, innovation is our passion. We have created the first in a series of innovative products destined to advance the science of radiation therapy treatment for cancer specialists and their patients. And that's just the beginning.

We value individual initiative, originality and intellectual curiosity. Small teams excel in achieving milestones and delivering results. Our team thrives on open communication, resourcefulness and rapid problem solving.

At Calypso® Medical, located in downtown Seattle, Washington, we are proud of our technical excellence, but most importantly, we are committed to making a difference in radiation therapy.

The Clinical Research Associate will oversee the initiation and progress of the organization’s clinical studies, including direct involvement with clinical sites, to ensure accomplishment of corporate goals.

Responsibilities include, but are not limited to:

• Interact directly with clinical sites, including clinical investigators and other health care professionals involved in the clinical study, and maintain a positive rapport with each site.
• Attend procedures to support sites and obtain product development feedback.
• Monitor clinical study data at sites to ensure regulatory and protocol compliance.
• Conduct other site visits as required.
• Generate clear and concise trip reports, site contact documentation, monthly status reports, and as required, clinical summaries.
• Manage product inventories for clinical studies.
• Maintain study documentation and ensure clinical studies are conducted in a timely manner and within site budgets.
• Assist in generation of protocols and site training materials.
• Ensure compliance with corporate and regulatory requirements.

Qualifications:

• Life science, health science or equivalent degree.
• 5+ years experience with monitoring clinical studies involving complex medical devices.
• Proficient in FDA regulations for clinical studies and medical devices.
• Ability to travel 50% of the time.
• Experience with medical instrumentation and documentation of patient information.

Calypso® Medical Technologies, Inc.

Email: jobs@calypsomedical.com

Calypso® Medical Technologies, Inc. is an Equal Opportunity Employer

Submitted: 12/29/2005