Clinical Research Associate

Essential Functions:

• 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) virtually and onsite
• Interact with cross functional team (Quality, Regulatory, R&D, etc.)
• Participates in and adheres to the Quality Initiatives and SOPs
• 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.)
• Prepare and present data reports
• Independent and proactive personality
• Other duties as assigned
• Willingness to travel to perform site monitoring functions

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
• Preferred: Medical Device clinical trial experience

Skills and Ability Requirements:

• Microsoft Office/Excel/PowerPoint
• Excellent organizational skills
• Excellent communication skills – written and verbal
• Always maintain corporate confidentiality

Cortex is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.