Consultant, CRA - Galveston - confidential

Description

Consultant, CRA / Clinical Monitor – Medical Device (Oncology)

Galveston, TX (Onsite Monitoring Required)

3+Month Contract | Immediate Start

Overview

Peritia is supporting a MedTech client advancing an innovative electrosurgical ablation device designed to improve surgical outcomes in breast-conservation surgery.

We are seeking an experienced Clinical Research Associate (CRA) / Clinical Monitor to support a pilot medical device study evaluating ablation technology in breast cancer patients.

This is an excellent opportunity for a hands-on clinical monitor with oncology and medical device experience who thrives in early-stage, fast-paced study environments.

The Role

The CRA will play a critical role in ensuring subject safety, regulatory compliance, and high-quality data collection for a small pilot study (single site).

This individual will work closely with the Clinical Trials Manager and cross-functional teams to support study oversight and monitoring activities.

Key Responsibilities

• Conduct site initiation, interim monitoring, and closeout visits (onsite and/or remote as appropriate)
• Ensure compliance with protocol, GCP, ISO 14155, and applicable regulatory requirements
• Perform targeted source data verification (SDV) and data review
• Verify informed consent documentation and process
• Monitor subject safety, including AE/SAE reporting
• Review device accountability and documentation
• Assess protocol deviations and support corrective actions
• Provide site training/retraining as needed
• Prepare monitoring reports and follow-up documentation
• Collaborate cross-functionally with Clinical Operations, Data Management, and Medical teams

Qualifications

• Bachelor's degree in Life Sciences, Nursing, or related field
• Prior CRA / site monitoring experience
• Experience supporting medical device clinical trials
• Strong knowledge of GCP and ISO 14155
• Experience in pilot, feasibility, or early-phase studies
• Strong communication and site management skills

Preferred Experience

• Breast cancer clinical trial experience
• Ablation technologies (thermal, RF, microwave, cryoablation, etc.)
• Oncology device or interventional procedure background
• Imaging-guided procedure familiarity
• Experience in startup or emerging MedTech environments