Clinical Quality Auditor — Trials & Compliance

Pinnacle Clinical Research- A Summit Solution; Springfield (NJ); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401k

Medical, dental, vision

PTO 3 weeks

14 holidays

Scrub voucher

Job summary

Summit Pinnacle Clinical Research in New Jersey seeks a Quality Associate to perform independent audits of trial activities and documentation, ensuring data accuracy and regulatory compliance. You will build strong relationships with internal staff and external vendors and report to the VP of Compliance.

Under supervision, you will conduct quality and regulatory duties and support process improvements. The role requires 2–4 years in clinical research QA/Regulatory, CPT/GCP familiarity, and

Qualifications

• Bachelor’s degree in scientific field or equivalent combination of education, training and experience.
• Proficiency in Microsoft Office applications (Word, Excel, Outlook, PowerPoint).
• Familiarity with clinical trial management systems (CRMs) such as Clinical Research IO.

Responsibilities

• Perform quality audits on study documents across therapeutic areas and phases.
• Support site staff training, including creating and presenting QA content.
• Write QA audit or QC reports and communicate findings to the team.
• Ensure SOPs/GCP compliance and accurate reporting of inspection results.
• Maintain QA records and notify management of quality trends.

Skills

Analytical skills

Attention to detail

Time management

Oral and written communication

Discretion with confidential info

Education

Bachelor’s degree in scientific field

Tools

Microsoft Office

Clinical Research IO

Job description

Summit Pinnacle Clinical Research in New Jersey seeks a Quality Associate to perform independent audits of trial activities and documentation, ensuring data accuracy and regulatory compliance. You will build strong relationships with internal staff and external vendors and report to the VP of Compliance.

Under supervision, you will conduct quality and regulatory duties and support process improvements. The role requires 2–4 years in clinical research QA/Regulatory, CPT/GCP familiarity, and