Senior Research Quality Assurance Analyst

Temple University Health System • Philadelphia, PA

3d

About The Position

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.

Requirements

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

Nice To Haves

• Master's Degree Science or related healthcare discipline
• Graduate of an accredited school of nursing
• Cert Clin Research Coordinator
• Cert Clin Research Associate
• Cert Clin Research Prof
• Assn Clin Res Prof - Cert Prof
• PA Registered Nurse License
• PA Practical Nurse License
• Multi State Compact RN License

Responsibilities

• 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.
• 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.
• Helps 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.
• Works with the QA Manager to develop metrics for reporting to senior leadership and delivers metrics in standard timeframe.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior