Note: The job is a remote job and is open to candidates in USA. AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. The Clinical Research Associate II will manage assigned clinical investigative sites, support study start-up and execution, conduct clinical monitoring visits, and coordinate site activities from start-up through closure while ensuring compliance with protocols, GCP, ICH, FDA, and applicable regulations.
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. 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
Skills
- * 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
- * Ability to manage role/responsibility independently
- * 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
- * Ability to create and manage key internal and external partnerships
- * Excellent written and verbal communication skills
- * Experienced user Microsoft Office software including WORD, Excel, and PowerPoint
- * Ability to travel up to 50%
- * Ability to regularly walk, sit, or stand as needed
- * Ability to occasionally bend and push/pull as needed
- * 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
Benefits
- Medical & Dental beginning day 1 of employment
- 401K plus match
- 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads
- Volunteer Time off
- Pet Insurance
- Corporate-based employees also have full access to our on-site fitness center and cafeteria
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