Job Information
Atricure, Inc. Clinical Research Associate II in Cincinnati, Ohio
Clinical Research Associate II Cincinnati, OH, USA * Mason, OH, USA * Minneapolis, MN, USA * Minnetonka, MN, USA Req #1992 Friday, March 22, 2024 AtriCure, 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 AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure'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 AtriCure.com or follow us on Twitter @AtriCure. 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. 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. 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 AtriCure'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. ESSENTIAL FUNCTIONS OF THE POSITION: 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 regulationsConduct initial and ongoing study training of site personnel throughout the clinical studyMonitor and report to ATRC site enrollment activitiesVerify that all research staff and facilities have adequate resources and qualifications and are maintained throughout the course of the studyAssist with the preparation of clinical study devices and verify the accountability of investigational devices are properly received, tracked, and secured at the study siteEnsure 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