Clinical Trial QA Auditor

Pinnacle Clinical Research- A Summit Solution; Bellaire (TX); In loco; USD 60.000 - 85.000; Tempo pieno

Vantaggi offerti da questo lavoro

401k

Medical, dental, vision

Paid time off

Descrizione del lavoro

Pinnacle Clinical Research- A Summit Solution is seeking a Quality Associate to conduct independent audits of trial activities and documents to ensure data accuracy and regulatory compliance with protocol, SOPs, GCP, and applicable regulations. This role reports to the VP of Compliance and partners with internal staff and external vendors.

Under supervision, you will perform QA duties across disciplines, support audit reporting, assist with training, maintain QA records, and communicate

Competenze

• Bachelor’s degree in a scientific field or equivalent experience.
• 2–4 years of clinical research/regulatory experience.
• Familiarity with CFR, GCP, HIPAA preferred.

Mansioni

• Perform QA audits of study documents and activities.
• Audit phases of laboratory and clinical studies and issue QA statements.
• Assist with QA reports and communicate findings to the team.
• Train site staff and develop quality content.
• Ensure SOPs are current and followed across phases.
• Coordinate regulatory submissions to IRB and sponsor.

Conoscenze

Analytical skills

Problem solving

Communication skills

Time management

Regulatory understanding

Formazione

Bachelor’s degree in scientific field

Strumenti

Clinical Research IO

Descrizione del lavoro

Pinnacle Clinical Research- A Summit Solution is seeking a Quality Associate to conduct independent audits of trial activities and documents to ensure data accuracy and regulatory compliance with protocol, SOPs, GCP, and applicable regulations. This role reports to the VP of Compliance and partners with internal staff and external vendors.

Under supervision, you will perform QA duties across disciplines, support audit reporting, assist with training, maintain QA records, and communicate