Clinical Research Associate II

Position Summary

The Clinical Research Associate II (CRA II) will be a key contributor to AtriCure’s clinical affairs department and primarily responsible for the site management of assigned clinical investigative sites. The CRA II will assist with the implementation and execution of study protocols and associated study documents for clinical trials, including clinical monitoring of AtriCure studies.

Essential Functions Of The Position

• Aid in the study development and start-up process, including protocol review, informed consent development, CRF design, EDC testing, and preparation of site-specific logs/documentation and investigator study files.
• Verify that the investigator and research staff follow the approved protocol and all GCP procedures.
• Manage study sites to ensure compliance with study protocol, GCP/ICH, and applicable regulations.
• Conduct initial and ongoing study training of site personnel throughout the clinical study.
• Coordinate site activities from site start-up to site closure as needed.
• 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.
• Prepare clinical study devices and ensure accountability of investigational devices are properly received, tracked, and secured at the study site.
• Report adverse events, concomitant medications, and inter-current illnesses 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.).
• Able to work on multiple projects as departmental priorities change.

Additional Essential Functions Of The Position

• Able to work under fast-paced conditions.
• Able to make decisions and use good judgement.
• Able to prioritize various duties and multitask as required.
• Able to successfully work with others.

Basic Qualifications

• Bachelor’s degree in a science or related technical field required or demonstrated equivalent combination of education, training and experience.
• Minimum two years of CRA experience.
• Comprehensive knowledge of ISO, GCP, ICH, FDA and other applicable regulations governing the conduct of clinical trials.
• Recognize problems, trends and react to resolve issue quickly and to bring effect resolution.
• Experience working with electronic data capture systems.
• Strong attention to detail and an ability to prioritize and juggle multiple/competing issues.
• Experienced user Microsoft Office software including WORD, Excel, and PowerPoint.

Preferred Qualifications

• Experience with medical device clinical trials desired but not required.
• Prior experience with cardiovascular clinical trials.
• Understanding of basic anatomy and physiology, electrophysiology and arrhythmias.
• Registered Nurse with previous clinical research experience as either a CRA or Study Coordinator.
• CCRA or CCRP Certification.