- 26-Nov-2013 to 31-Mar-2014 (PST)
- 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.
- 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.
- 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.
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