Quality Assurance Coordinator (Clinical Research)

CenExel Clinical Research is seeking a Quality Assurance Coordinator (Clinical Research) to ensure highest standards of data quality and study participant safety, and adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines.

Requirements

• Assists the QA Manager in the development, implementation and follow-up of quality assurance programs
• Reviews follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis
• Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports
• Prepares for internal and external audits and FDA inspections
• Attends staff meetings and site initiation visits as needed

Benefits

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