Atossa Genetics is a women’s healthcare company specializing in the development of proprietary medical devices and laboratory services to stratify, assess, profile, and monitor the breast health in patients.

We accept enthusiastic, high quality undergraduate or graduate students interested in learning the industry as interns. Stipend may be awarded depending on the skills and experiences. Please send your resume and contact information for two references to

Current Opportunities

Clinical Research Associate (in-house)

This is an in-house (Seattle based) position that will assist the Clinical Project Manager in implementation and oversight of device and pharmaceutical clinical studies at Atossa Genetics. The CRA will manage the clinical site activities either directly or via vendor oversight. Manages or assists in investigator selection, analysis of potential patient recruitment, preparation and/or review of trial related documentation (e.g. Investigator’s Brochure, Protocol, Case report forms, consent documents, confidentiality agreements, etc.), organizes Ethics committee submissions with follow through to ensure successful outcome.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Oversees and/or performs clinical site oversight from investigational site start-up to closure
  • Builds strong, long-term relationships with the investigators, study coordinators, and other research personnel based on respect, knowledge, and commitment to appropriate clinical research practices
  • Supervises study-related clinical activities at sites to ensure project-specific requirements/metrics are achieved
  • Assists in selection, recruiting and management of contract clinical research associates
  • Ensures timely execution of clinical studies per company goals
  • Assures that study-related clinical activities are conducted in compliance with GCP/ICH guidelines, SOPs, and project requirements
  • Reviews monitoring and other study activity reports to assure that project timelines are achieved and that company SOPs, GCP/ICH guidelines, and FDA regulations are being followed
  • Monitors and/or oversees the assigned clinical trial following company SOPs and in accordance with GCP
  • Tracks CRF status and ensure the timely completion CRFs
  • Maintains the site trial master file
  • Prepares site study materials, ensure site distribution and maintenance, including investigational product accountability
  • Assists in the planning and implementation of site training or corrective action as necessary
  • Assists sites in development and implementation of patient recruitment strategies
  • Ensures that all required study documents and materials in support of study execution (e.g. start-up, communication, monitoring, and study execution) are complete, accurate and are maintained and updated as required
  • Assists with site contract execution
  • Communicates with Clinical Project Manager on project status and clinical site needs/issues
  • Provides, oversees or facilitates site training
  • Identifies potential investigators
  • Participates in global conference calls and meetings to review progress of ongoing clinical trials
  • Participates in departmental planning sessions, and SOP development

Education, Experience and/or Skills Required

  • Bachelor’s Degree in Scientific/Health related field
  • 2-3+ years Clinical Research experience required, including relevant Clinical Trial Monitoring required
  • Experience with vendor management
  • Experience in a global or similarly structured organization
  • Knowledge of Good Clinical Practice (CGP) and FDA regulations is expected. Experience with Institutional Review Board (IRB) preparations and submission preferred
  • Experience reviewing clinical protocols
  • Ability to exercise judgment and determine appropriate action
  • Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, external vendors, and clinical sites
  • Ability to work independently and manage deadlines
  • Approximately 25% travel. International travel may be required
  • CRA certificate a plus

To apply for this position please send your resume to