Clinical Research Associate II
About The Position
The Clinical Research Associate II (CRA II) contributes to AtriCure’s clinical affairs department and is primarily responsible for managing assigned clinical investigative sites. The role assists with implementation and execution of study protocols and related documents, including clinical monitoring, and coordinates site activities from start-up through closure as needed. The CRA II works closely with Clinical Project Managers and Senior CRAs to meet study deliverables. The role supports start-up for clinical investigational protocols, including protocol review, informed consent development, CRF design, EDC testing, and preparation of site-specific logs, documentation, and investigator study files. The CRA II may participate in study review meetings and attend scientific meetings and industry conferences as required. Site visits include Site Qualification, Site Initiation, Interim Monitoring, and Close Out Visits.
Requirements
- Bachelor’s degree in a science or related technical field, or an equivalent combination of education, training, and experience.
- At least two years of CRA experience.
- Comprehensive knowledge of ISO, GCP, ICH, FDA, and other applicable regulations governing clinical trials.
- Ability to manage role responsibilities independently.
- Ability to recognize problems and trends, respond quickly, and resolve issues effectively.
- Experience working with electronic data capture systems.
- Strong attention to detail and ability to prioritize and manage multiple competing issues.
- Ability to create and manage key internal and external partnerships.
- Excellent written and verbal communication skills.
- Experienced user of Microsoft Office software, including Word, Excel, and PowerPoint.
- Ability to travel up to 50%.
- Ability to regularly walk, sit, or stand as needed and occasionally bend and push or pull as needed.
- Ability to pass a pre-employment drug screen and background check.
- Regular and predictable work performance, ability to work in fast-paced conditions, exercise good judgment, prioritize and multitask, and work successfully with others.
Nice To Haves
- Experience with medical device clinical trials.
- Prior experience with cardiovascular clinical trials.
- Understanding of basic anatomy and physiology, electrophysiology, and arrhythmias.
- Registered Nurse with prior clinical research experience as a CRA or Study Coordinator.
- CCRA or CCRP certification.
Responsibilities
- Assist Clinical Project Managers and Senior CRAs with study development and start-up, including informed consent development and internal review before IRB/EC submission, and collection of start-up documentation from clinical investigational sites.
- Verify that investigators and research staff follow the approved protocol and GCP procedures.
- Conduct weekly maintenance and management of study sites to ensure compliance with the study protocol, GCP/ICH, and applicable regulations.
- Conduct initial and ongoing study training for site personnel.
- Monitor and report site enrollment activities to AtriCure.
- Verify that research staff and facilities have adequate resources and qualifications throughout the study.
- Assist with preparation of clinical study devices and verify that investigational devices are properly received, tracked, and secured at study sites.
- Ensure adverse events, concomitant medications, and inter-current illnesses are reported on the CRF in accordance with the protocol.
- Communicate protocol, SOP, GCP, and regulatory deviations to investigators and ensure corrective action is implemented.
- Review queries and assist in resolving DCFs.
- Participate in project team meetings and departmental development initiatives, such as training and SOP development or updates.
- Manage multiple projects as departmental priorities change.
- Perform additional duties as assigned.
Benefits
- Medical and dental coverage beginning on day one of employment.
- 401(k) with company match.
- 30 days of paid parental leave, in addition to maternity leave.
- Volunteer time off.
- Pet insurance.
- Corporate-based employees have access to an on-site fitness center and cafeteria.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
