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 #J-18808-Ljbffr
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