Consultant, CRA / Clinical Monitor – Medical Device (Oncology)
Behavioral Health Market Context
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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
- •3 more items(s)
Responsibilities
- •Galveston, TX (Onsite Monitoring Required)
- •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 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
- •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
- •12 more items(s)