Clinical Investigator Site Audit Consultant - Cardiovascular Trial

Job Description

Job Description

Clinical Investigator Site Audit Consultant – Cardiovascular Trial

Location: Houston Area, Texas
Work Arrangement: Onsite

Duration: Approximately 21 hours total
Duration: 2-day audit
Start: Q4 2026

Position Overview

We are seeking an experienced Clinical Investigator Site Audit Consultant to conduct a routine, onsite investigator site audit for a cardiovascular clinical trial in the Houston area.

The consultant will independently evaluate investigator site activities and documentation to assess compliance with the clinical trial protocol, applicable Good Clinical Practice (GCP) expectations, and relevant regulatory requirements.

This is a focused, two-day engagement requiring an experienced clinical quality professional who can efficiently conduct a thorough investigator site audit, identify potential compliance gaps, and clearly communicate observations requiring follow-up.

Key Responsibilities

• Conduct a routine, two-day investigator site audit at a clinical research site.
• Review site-level clinical trial activities and documentation for compliance with the study protocol and applicable GCP and regulatory requirements.
• Evaluate investigator site processes and records relevant to appropriate trial conduct.
• Identify and clearly document audit observations and potential compliance gaps.
• Communicate significant findings and areas requiring follow-up to appropriate stakeholders.
• Conduct audit activities professionally and efficiently within the scheduled onsite timeframe.

Required Qualifications

• Demonstrated experience conducting investigator site audits for clinical trials.
• Strong knowledge of Good Clinical Practice (GCP) and clinical research compliance requirements.
• Experience reviewing clinical trial site documentation, processes, and investigator responsibilities.
• Ability to independently conduct an onsite audit and effectively communicate audit observations.
• Availability to complete a two-day onsite audit in the Houston area during Q4 2026.

Work Arrangement

This is a short-term, onsite consulting engagement requiring two days at an investigator site in the Houston area.

Ideal Candidate

The ideal consultant is an experienced clinical quality auditor with a strong background in investigator site audits, GCP compliance, and clinical trial site operations who can independently execute a focused routine audit within a two-day onsite engagement.