ProTrials Research, Inc.
  • 26-Nov-2013 to 31-Mar-2014 (PST)
  • Quality
  • Sunnyvale, CA, USA
  • Full Time

Joining ProTrials Research, Inc. means you will have an opportunity to be part of our top-notch Clinical Research Professionals. You will work in a collaborative team environment focused on excellence, integrity, and high standards. We offer our employees great benefits, including paid time off, medical & dental coverage, 401(k) retirement savings, Flexible Spending Accounts, life and disability.

In this position, the Sr. QA Associate/ QA Manager will provide consultation in the interpretation of GCP regulations, guidelines, policies, and procedures to ProTrials staff; plan, conduct, and report independent Good Clinical Practice (GCP) Quality Assurance (QA) audits of internal systems/procedures and ProTrials vendors against applicable regulations and procedures; support, maintain, review QA systems – Controlled Documentation System, Corporate Training program, and Corrective Action and Preventative Actions (CAPAs); and support/provide management with quality metrics and updates.


ESSENTIAL DUTIES

  • Manage the QA Document Control system.
  • Assist in SOP writing and/or review.
  • Assist in preparing and hosting Client audits at ProTrials.
  • Write/Review/Track CAPAs for ProTrials and Client audits.
  • Conduct audits (internal systems and vendor) for ProTrials.
  • Provide QA/compliance advice to ProTrials staff.
  • Perform other related duties as assigned.


OTHER QUALIFICATIONS

  • Strong knowledge of FDA GCP and ICH regulations, guidelines, and standards governing regulated clinical research is required.
  • Working knowledge and understanding of drug development and global clinical regulatory environment.
  • Outstanding interpersonal, oral and written communication skills.
  • Detail oriented.
  • Available to travel 10% of the time.


EDUCATION AND/OR EXPERIENCE

  • Bachelor's degree in scientific or related discipline, or equivalent work experience.
  • Minimum of 5-7 years industry experience, with at least 3-5 years in clinical QA.
  • Direct experience with internal/external clinical systems and process audits.
  • Experience in QA audits of Clinical Investigators and Clinical Vendors.
  • Experience in development of SOPs.
  • Strong software and computer skills; including MS Word, Excel, PowerPoint, and Outlook.Excellent presentation skills.

 




This position has been closed and is no longer available.
ProTrials Research, Inc.

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