Senior Clinical Research Integrity Analyst

Develops the requirements necessary for attaining and maintaining compliance with the FDA and other regulatory bodies for clinical trial research both from a documentation and process level based on best practice standards. Creates and delivers educational sessions that promote adherence to ICH-GCP guidelines, ensuring that data reported is accurate. The Sr Research QA Analyst leads the team with pharmaceutical audit preparations and audit responses. Performs eligibility verifications and chart reviews. Assists with the coordination of NCI and NCTN audits. Research QA Analysts are an integral part of the infrastructure development and help to coordinate projects, and communicates status and improvement areas to leadership. Implements and coordinates department-wide initiatives such as research quality management or clinical trial education efforts. The Sr Research QA Analyst works with the QA Manager to develop metrics for reporting to senior leadership and delivers metrics in standard timeframe.EducationBachelor's Degree RequiredMaster's Degree Science Or Related Healthcare Discipline PreferredOther Graduate of an accredited school of nursing PreferredExperience5 years experience in a health care environment as a Clinical Research Associate, Clinical Research Coordinator, Clinical Research Nurse or Medical Chart Auditor Required5 Years Experience In Clinical Trials Auditing Required5 years experience in oncology RequiredLicensesCert Clin Research Coordinator Preferred OrCert Clin Research Associate PreferredCert Clin Research Prof PreferredAssn Clin Res Prof - Cert Prof PreferredPA Registered Nurse License PreferredPA Practical Nurse License Preferred