Clinical Research Associate II

Atri Cure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use Atri Cure technologies for the treatment of Afib and reduction of Afib related complications. Atri Cure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib.

Atri Cure's Atri Clip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. Atri Cure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. Atri Cure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures.

For more information, visit  or follow us on Twitter @Atri Cure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

The Clinical Research Associate II (CRA II) will be a key contributor to Atri Cure'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 Atri Cure studies. This also includes the coordination of site activities from site start-up to site closure as needed.

The CRA II will work closely with the Clinical Project Managers and Sr. CRAs to ensure the study is executed to meet project deliverables.

The CRA II will be responsible for the study start up process for Atri Cure's Clinical Investigational protocols, which includes and is not limited to the following: protocol review, Informed Consent Development, CRF design, EDC testing, preparation of site-specific logs/documentation and investigator study files. The CRA II will participate as needed, in study review meetings and attend scientific meetings and industry conferences as required.

The CRA II will also conduct site visits including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close Out Visits.

• 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. Collection of startup documentation from clinical investigational site
• 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

• Regular and predictable work performance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgement
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned

• Bachelor's degree in a science or related technical field required or demonstrated equivalent combination of education, training and experience
• Minimum two years…