Quality Assurance Coordinator

CenExel Clinical Research is seeking a Quality Assurance Coordinator to ensure high standards of data quality and subject safety are maintained, as well as study protocols, SOPs/SWPs, ICH/GCP and IRB guidelines, federal regulations are consistently being followed.

Requirements

• Review assigned study participant study data/source binders/Informed Consents to ensure compliance with study protocols and related guidelines
• Ensure all books and subject data are approved prior to monitoring visits and remote source verification
• Participates in study start up activities including the review of source documentation.
• Implement Quality Assurance Processes
• Responsible for Quality Assurance and preparation of study related material for FDA & Sponsor audit with assistance as necessary.
• Ensure proper correction of any queries or issues noted in research data
• Attend site initiation meetings and other study related meetings as required
• Identify needed training programs for clinical research staff based upon quality assurance review and reports.
• Evaluate and present Quality Assurance findings/metrics to appropriate staff members and managers.
• Answer inquiries from Operations staff when protocol or study-related questions arise
• Escalate and present major findings to the Director of Quality
• Identifies and assists in overseeing training programs for study staff and supporting departments based upon review metrics
• Conducts onboarding of new employees and maintains tracking of training statuses for all employees
• Quality check of all source documentation after created by staff to ensure ready for current use; creates source on an as needed basis
• Assumes other duties and responsibilities as assigned.

Benefits

• Health Insurance
• Dental
• Vision
• LTD
• STD
• Life Ins
• 401k