Clinical Research Quality Auditor

ADP, Inc.; Bellaire (TX); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

401k

Medical, dental, vision benefits

Paid time off

13 holidays

Job summary

Pinnacle Clinical Research seeks a Quality Associate to perform independent audits of clinical trial activities and documentation to ensure adherence to protocol, SOPs, GCP, and regulatory requirements.

The role emphasizes building strong relationships with internal staff and external vendors, training site staff, and reporting findings to the Internal Study Team. Supervision by a mentor/coach and reporting to the VP of Compliance are included.

Qualifications

• Bachelor’s degree in scientific area of study or equivalent.
• 2–4 years of experience in clinical research quality/regulatory roles preferred.
• Knowledge of CFR, GCP, HIPAA, ICH guidelines.
• Proficiency with Microsoft Office applications (Word, Excel, Outlook, PowerPoint).
• Familiarity with clinical trial management systems, preferably Clinical Research IO.

Responsibilities

• Perform QA audits of study documents and trial activities to ensure SOPs and GCP are followed.
• Identify and communicate opportunities for process improvements based on audit findings.
• Assist with writing QA audit and QC reports and train site staff as needed.
• Maintain QA records and study files with organized documentation.
• Communicate findings clearly to internal study teams and management.

Skills

Regulatory knowledge

Quality assurance

Documentation

Education

Bachelor’s degree in science

Tools

Clinical Research IO

Job description

Pinnacle Clinical Research seeks a Quality Associate to perform independent audits of clinical trial activities and documentation to ensure adherence to protocol, SOPs, GCP, and regulatory requirements.

The role emphasizes building strong relationships with internal staff and external vendors, training site staff, and reporting findings to the Internal Study Team. Supervision by a mentor/coach and reporting to the VP of Compliance are included.