Case Support & Site Engagement
• Provide on-site or on-line procedure support during investigational DCB angioplasty cases, ensuring adherence to study protocol, device handling SOPs, and ICH-GCP requirements.
• Act as the technical and clinical liaison between investigators, cath lab teams, and sponsor during case execution.
• Support subject eligibility verification, informed consent review, and device accountability in compliance with 21 CFR Part 812 and ISO 14155 standards.
• Document case-related observations, protocol deviations- if any, and procedural data in accordance with the monitoring plan.
Clinical Operations & Documentation
• Assist in site initiation, training, and qualification activities related to IDE protocol.
• Maintain real-time records of procedural outcomes, adverse events, and device usage logs.
• Support CRA/monitoring teams with source data verification (SDV) and query resolution.
• Ensure compliance with regulatory, ethical, and sponsor-specific quality standards.
Cross-functional Collaboration
• Work closely with R&D, Regulatory Affairs, and Clinical Project Management to provide field
feedback and procedural insights.
• Participate in risk assessments, monitoring reviews, and data quality meetings.
• Provide training or refresher sessions to cath lab staff on investigational device handling, use of the Investigational device and Trial Protocol as needed.
Qualifications & Experience
• Bachelor’s degree in Nursing, Biomedical Engineering, Life Sciences, or equivalent clinical field.
• Minimum 2–5 years of experience in clinical research, cath lab, or cardiovascular device and Clinical trials.
• Hands-on experience with angioplasty, stent, or drug-coated balloon interventions in CAD and PAD space.
• Familiarity with FDA IDE, ICH-GCP E6(R2), and EU MDR or other regional regulatory frameworks.
• Strong understanding of clinical trial documentation, source data verification, and informed consent processes.
Preferred:
• Experience supporting interventional cardiology (CAD) and Peripheral artery disease (PAD) device studies or drug-device combination products.
• Prior role as clinical specialist, field clinical engineer, Cath lab nurse/technician, or clinical research associate in cardiovascular studies.
• Excellent communication and presentation skills with the ability to engage physicians and clinical teams.
Key Competencies
• Strong situational awareness in cath lab environment.
• Attention to detail, documentation accuracy, and compliance mindset.
• Ability to travel to investigational sites across the US as required (up to 60%).
• Team-oriented, adaptable, and calm under procedural pressure.
