Careers

 

Position: Clinical Research Associate (CRA) II

Status: Regular, Full-Time, Exempt Position Located in the San Francisco Area

Job Summary: We currently have an opportunity for a Clinical Research Associate II who will be responsible for managing several U. S. clinical trials. The position will be based in Redwood City, California, and will have moderate domestic and international travel requirements.

Responsibilities:

  • Monitor activities at clinical study sites to assure adherence to GCP, SOPs and study protocols
  • Assist in the development of CIPs, protocols, CRFs, SOPs and IRB submissions for clinical trials
  • Conduct study initiation, monitoring and closeout visits
  • Review regulatory documents as required and prepare site visit reports
  • Manage electronic databases and conduct in-house monitoring
  • Perform data verification, validation and audits
  • Assist in preparation of FDA submissions
  • Assist in preparation of publications and presentations
  • Participate in clinical operation initiatives and projects as assigned

Position Qualifications:

  • Bachelor degree in nursing or life sciences
  • CCRA preferred but not required
  • 5 years of CRA experience in the U. S.
  • Extensive experience preparing CIPs, CRFs, ICFs, SOPs, and IRB submissions
  • Extensive experience in monitoring medical device clinical trials
  • Extensive knowledge of clinical research requirements and cross-functional understanding of clinical research methodology
  • Extensive experience in managing electronic database systems
  • Expert knowledge of GCP and ICH guidelines and regulations
  • Excellent writing skills and ability to prepare clinical and regulatory reports
  • Effective written and verbal communication skills
  • Well organized, enthusiastic and detail oriented
  • Proficient computer skills
  • Ability to complete tasks independently in an accurate and timely manner
  • Ability and willingness to travel up to 25% of time in the U. S.
  • A good understanding of GI anatomy and physiology would be a plus

Equipment to be used in Performance of Job:

  • Computer/laptops/printer
  • Telephone/Blackberry
  • Fax Machine
  • General office equipment

E-mail résumés to hr@endogastricsolutions.com or send to:

HR Manager
EndoGastric Solutions, Inc.
8210 154th Avenue NE
Redmond, WA 98052