US: Quality Data Specialist
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please visit http://sqa.fyicenter.com
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
Team SQAFYI - Software QA Resource FYI