In House Clinical Research Associate - Cortex

At Cortex, we are developing a technologically advanced mapping and ablation solution for Atrial Fibrillation (Afib), the most common heart rhythm disorder, with determined passion. We aim to enable more precise, personalized therapy planning and delivery to optimize clinical outcomes and safety for Afib patients while simplifying workflows and improving procedural efficiency. Our technology suite will include diagnostic and pulsed field ablation catheters and a comprehensive mapping and navigation solution powered by Ablacon’s innovative Electrographic Flow® (EGF) mapping technology.

As a Clinical Research Associate you will independently monitor clinical research study sites and electronic data.

Responsibilities:

• Assist in the identification and qualification of study sites
• Assist with the creation and collection of required study documents both internally and with the investigational study sites
• Monitor case report forms and electronic data for quality, completeness, and accuracy
• Interact with data management and study sites with generation and reconciliation of queries
• Provide answers to common clinical investigation protocol related questions under the supervision of the Clinical Director or Program Manager
• Monitor study sites (Site Initiation Visits, interim monitoring visits, and close-out visits)
• Interact with cross functional team (Quality, Regulatory, R&D, etc.)
• Participates in and adheres to the Quality Initiatives and SOPs
• Other duties as assigned
• Initial and transitional education for clinical centers and research personnel on clinical study protocols, clinical study processes, products and applications.
• Preparation and implementation of clinical study training materials (checklists, brochures, study binders, etc.)
• Independent and proactive personality
• Willingness to travel to perform site monitoring functions and come into office when not traveling to monitoring sites

Qualifications:

• B.A. or B.S. in biological/health sciences
• Minimum of 1-3 years of experience as a Clinical Research Associate
• Preferred: Minimum of 1 year of research and development experience

Requirements:

• Microsoft Office/Excel/Powerpoint
• Excellent organizational skills
• Excellent communication skills – written and verbal • Maintain corporate confidentiality at all times • Able to work both independently and as part of a team • Ability to establish and maintain trust