RESEARCH QA ANALYST

Temple University Health System • Philadelphia, PA

1h

About The Position

The Research Quality Assurance Analyst reviews 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. Promotes adherence to ICH-GCP guidelines by ensuring that data reported is accurate and complete and guarantees that the rights and safety of participants in clinical research are protected. This is accomplished by serving as a resource for the entire Office of Clinical Research (OCR) staff. Assists with pharmaceutical audit preparations and audit responses. Performs eligibility verifications and chart reviews. Research QA Analysts are an integral part of the infrastructure development and help to coordinate projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial education efforts.

Requirements

• Bachelor's Degree Required
• 1 year experience in a health care environment as a Clinical Research Associate, Clinical Research Coordinator, Clinical Research Nurse or Medical Chart Auditor Required

Nice To Haves

• Graduate of an accredited school of nursing Preferred
• Combination of relevant education and experience may be considered in lieu of degree Required
• 2 years experience in clinical trials auditing Preferred
• 2 years experience in oncology Preferred
• Cert Clin Research Coordinator Preferred
• 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

Responsibilities

• Reviews requirements for FDA and other regulatory body compliance in clinical trial research (documentation and process).
• Promotes adherence to ICH-GCP guidelines by ensuring data accuracy and completeness.
• Guarantees protection of participant rights and safety in clinical research.
• Serves as a resource for the Office of Clinical Research (OCR) staff.
• Assists with pharmaceutical audit preparations and audit responses.
• Performs eligibility verifications and chart reviews.
• Coordinates projects and communicates status and improvement areas to leadership.
• May implement and coordinate department-wide initiatives such as research quality management or clinical trial education efforts.

What This Job Offers

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