Senior Research Quality Assurance 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.

Education
Bachelor's Degree Required
Master's Degree Science or related healthcare discipline Preferred
Other Graduate of an accredited school of nursing Preferred

Experience
5 years experience in a health care environment as a Clinical Research Associate, Clinical Research Coordinator, Clinical Research Nurse or Medical Chart Auditor Required
5 years experience in clinical trials auditing Required
5 years experience in oncology Required

Licenses
Cert Clin Research Coordinator Preferred or
Cert Clin Research Associate Preferred
Cert Clin Research Prof Preferred
Assn Clin Res Prof - Cert Prof Preferred
PA Registered Nurse License Preferred
PA Practical Nurse License Preferred
Multi State Compact RN License Preferred Or