US: Quality Data Specialist

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 31-Mar-2015

Quality Data Specialist

Be an active member of Quality Assurance and Compliance Committee Perform random QA checks on patient binders and regulatory binder systems Ensure that all data collected is documented in accordance with ICH GCP guidelines Respond to sponsor data queries appropriately and adequately Complete Data Correction/Clarification Forms when appropriate to sponsor Run daily QA checks on data entered into eCRF systems per specific clinical trial protocols Work closely with Data Entry Clerk to ensure that all data is entered timely per company policy of 24-48 hours post visit completion

Oversee the preparation of patient source documents for use during trial participation. Update source as needed per Protocol Amendments as they arise Ensure that all patient and regulatory binders are, and continue to be, arranged per the site specific system for each assigned clinical trial File regulatory documentation as necessary into regulatory binders for all assigned clinical research trials

Document all work in computer project software. Use Clinical Conductor, Basecamp, and any other technologies proficiently. Update systems in real-time. Adapt to new technology; keep abreast of changes. Use project management software to improve productivity. Associate College Degree or Higher

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com