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Senior Research Quality Assurance Analyst at Temple University Health System

Philadelphia, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Aug, 26

Salary

0.0

Posted On

05 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

FDA Compliance, ICH-GCP Guidelines, Clinical Trial Auditing, Pharmaceutical Audit Preparation, Eligibility Verification, Chart Review, Quality Management, Metrics Reporting, Oncology Research, Regulatory Compliance

Industry

Hospitals and Health Care

Description

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

Responsibilities

Develops and maintains compliance requirements for clinical trial research according to FDA and regulatory standards. Leads pharmaceutical audit preparations and coordinates department-wide quality management initiatives.