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.
Seniority level
Associate
Employment type
Full-time
Job function
Research, Science, and Health Care Provider
Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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