Consultant, CRA / Clinical Monitor – Medical Device (Oncology
Listed on 2026-08-22
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Science
Clinical Research
Consultant, CRA / Clinical Monitor – Medical Device (Oncology) Galveston, TX (Onsite Monitoring Required) 3+Month Contract | Immediate Start Overview
Peritia is supporting a Med Tech 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 RoleThe 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
- 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
- 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 Med Tech environments
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