Remote Clinical Research Associate II - Med Device Trials

AtriCure, Inc.; Minnetonka (MN); Remote; USD 85,000 - 105,000; Full time

Benefits offered by this job

Medical & Dental beginning day 1

401K match

Parental Leave

Volunteer Time off

Pet Insurance

On-site fitness center and cafeteria

Job summary

AtriCure, Inc. is seeking a Clinical Research Associate II to contribute to the clinical affairs team, overseeing site management for assigned trials from start-up to close-out.

You will help implement protocols, prepare documents, and monitor site performance to meet project milestones. The CRA II will perform site visits, ensure GCP/ICH compliance, and collaborate with Clinical Project Managers to maintain study integrity.

Qualifications

• Bachelor’s degree in a science or related field.
• Minimum two years of CRA experience.
• Comprehensive knowledge of ISO, GCP, ICH, FDA and other applicable regulations governing the conduct of clinical trials.
• Ability to manage role/responsibility independently.
• Experience working with electronic data capture systems.
• Strong attention to detail and an ability to prioritize and juggle multiple/competing issues.
• Excellent written and verbal communication skills.
• Experienced user Microsoft Office software including WORD, Excel, and PowerPoint.

Responsibilities

• Assist Clinical Project Managers and Sr. CRAs in the study development and start-up process development of the informed consent form and internal review prior to submission to the IRB/EC.
• Verify that the investigator and research staff follow the approved protocol and all GCP procedures.
• Conduct weekly maintenance and management of study sites to ensure site compliance with study protocol, GCP/ICH, and applicable regulations.
• Conduct initial and ongoing study training of site personnel throughout the clinical study.
• Monitor and report to ATRC site enrollment activities.
• Verify that all research staff and facilities have adequate resources and qualifications and are maintained throughout the course of the study.
• Assist with the preparation of clinical study devices and verify the accountability of investigational devices are properly received, tracked, and secured at the study site.
• Ensure adverse events, concomitant medications, and inter-current illnesses are reported in accordance with the protocol on the CRF.
• Communicate deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to the investigator and ensure corrective action is implemented.
• Review queries and assist in the resolution of DCFs.
• Participate in project team meetings.
• Participate in departmental development initiatives (e.g. training, SOP development/updates, etc.)
• Ability to work on multiple projects as departmental priorities change

Skills

Excellent written and verbal comms

Detail oriented

Travel up to 50%

Electronic data capture systems

Education

Bachelor’s degree in science or related field

CCRA or CCRP Certification

Tools

Microsoft Office

Job description

AtriCure, Inc. is seeking a Clinical Research Associate II to contribute to the clinical affairs team, overseeing site management for assigned trials from start-up to close-out.

You will help implement protocols, prepare documents, and monitor site performance to meet project milestones. The CRA II will perform site visits, ensure GCP/ICH compliance, and collaborate with Clinical Project Managers to maintain study integrity.