CRA II – Cardio Medical Devices, 50% Travel

AtriCure; Mason, Minnetonka (OH, MN); In loco; USD 85.000 - 105.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical & Dental benefits

401K with match

Paid parental leave

Commitment to diverse, inclusive teams

Descrizione del lavoro

AtriCure, Inc. is seeking a Clinical Research Associate II (CRA II) to act as a key contributor in the clinical affairs group, handling site management for assigned investigative sites. You will aid in protocol implementation, documentation, and monitoring across studies to meet project deliverables.

The role involves site initiation to close-out visits, training of site staff, and coordination with Clinical Project Managers and Sr. CRAs.

Competenze

• Bachelor’s degree in science or related field required.
• Minimum two years of CRA experience.
• Knowledge of ISO, GCP, ICH, FDA regulations governing clinical trials.
• Ability to manage responsibilities independently and resolve issues.
• Experience with electronic data capture systems.
• Strong detail orientation and multitasking ability.
• Excellent written and verbal communication.
• Willingness to travel up to 50%.

Mansioni

• Assist with study development and startup activities, including consent forms.
• Ensure protocol, GCP/ICH compliance across sites.
• Maintain study sites and train site personnel.
• Monitor site enrollment and verify resources and facilities.
• Help prepare device accountability and regulatory documentation.
• Report adverse events and deviations; support corrective actions.
• Participate in team meetings and manage multiple projects.

Conoscenze

Clinical trial monitoring

GCP/ICH knowledge

Regulatory compliance

Documentation management

Communication skills

Project coordination

Travel willingness

Formazione

Bachelor's degree in science

Strumenti

EDC systems

Descrizione del lavoro

AtriCure, Inc. is seeking a Clinical Research Associate II (CRA II) to act as a key contributor in the clinical affairs group, handling site management for assigned investigative sites. You will aid in protocol implementation, documentation, and monitoring across studies to meet project deliverables.

The role involves site initiation to close-out visits, training of site staff, and coordination with Clinical Project Managers and Sr. CRAs.