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AtriCure

Sells ablation devices for atrial fibrillation

Clinical Research Associate 2

Clinical Research OperationsPosted on Nov 9
Full-timeRemote in USA$85k - $105k

About the Job

Requirements

  • A bachelor's degree in a science or related technical field is required, or an equivalent combination of education, training, and experience.
  • At least two years of clinical research associate experience is required.
  • Comprehensive knowledge of ISO, Good Clinical Practice, International Council for Harmonisation guidelines, FDA requirements, and other regulations governing clinical trials is required.
  • Ability to manage the role and responsibilities independently is required.
  • Ability to recognize problems and trends, respond quickly, and implement effective resolutions is required.
  • Experience working with electronic data capture systems is required.
  • Strong attention to detail and ability to prioritize and manage multiple competing issues are required.
  • Ability to create and manage key internal and external partnerships is required.
  • Experience using Microsoft Word, Excel, and PowerPoint is required.
  • Ability to travel up to 50% is required.
  • Ability to regularly walk, sit, or stand as needed and occasionally bend and push or pull is required.
  • Ability to pass a pre-employment drug screen and background check is required.

Responsibilities

  • Assist clinical project managers and senior clinical research associates with study development and start-up, including informed consent form development and internal review before submission to the IRB or ethics committee, and collect start-up documentation from clinical investigation sites.
  • Verify that investigators and research staff follow the approved protocol and all Good Clinical Practice procedures.
  • Conduct weekly maintenance and management of study sites to ensure compliance with the study protocol, Good Clinical Practice, International Council for Harmonisation guidelines, and applicable regulations.
  • Conduct initial and ongoing study training for site personnel throughout the clinical study.
  • Monitor and report site enrollment activities to AtriCure.
  • Verify that research staff and facilities have adequate resources and qualifications and maintain them throughout the study.
  • Assist with preparing clinical study devices and verify that investigational devices are properly received, tracked, and secured at the study site.
  • Ensure adverse events, concomitant medications, and intercurrent illnesses are reported in accordance with the protocol on the case report form.
  • Communicate deviations from the protocol, standard operating procedures, Good Clinical Practice, and applicable regulatory requirements to the investigator, and ensure corrective action is implemented.
  • Review queries and assist in resolving data clarification forms.
  • Participate in project team meetings.
  • Participate in departmental development initiatives, including training and standard operating procedure development and updates.
  • Work on multiple projects as departmental priorities change.
  • Maintain regular and predictable work performance and work under fast-paced conditions.
  • Make decisions using sound judgment, prioritize duties, and multitask as required.
  • Perform additional duties as assigned.

Desired Qualifications

  • Experience with medical device clinical trials is desired but not required.
  • Prior experience with cardiovascular clinical trials is preferred.
  • Understanding of basic anatomy and physiology, electrophysiology, and arrhythmias is preferred.
  • Registered Nurse status with prior clinical research experience as a clinical research associate or study coordinator is preferred.
  • CCRA or CCRP certification is preferred.

About the Company

AtriCure

Sells ablation devices for atrial fibrillation

AtriCure develops medical devices for atrial fibrillation (AF), including ablation systems, left atrial appendage management devices, and cryoablation tools used in open-heart and minimally invasive heart surgeries. Their devices deliver energy to heart tissue to create controlled lesions or support blood flow, helping treat AF and reduce stroke risk. They differentiate themselves with an AF-focused portfolio and provide hands-on training and support for clinicians to ensure proper use across surgical approaches. Their goal is to improve patient outcomes by offering reliable tools and comprehensive clinician education.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Mason, OH
Founded
1994

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