Clinical Research Associate II - Registry Studies

POSITION SUMMARY:

The Clinical Research Associate II – Registry Studies, will be a key contributor in supporting real-world initiatives at AtriCure. This position will be responsible for site management, and data monitoring of assigned registry projects undertaken in support of the Global Registry portfolio.As a member of the Scientific Affairs team, the role will report to the Manager, Global Registries, and collaborate closely with vendors, site research staff, Clinical Operations, and Data Management teams at AtriCure.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Serves as the primary point of contact for assigned registry study sites; collaborate with participating registry sites and field team to execute on timely site activations, subject enrollment goals; manage site communications and study-related activities; accountable for data integrity, patient protections, and regulatory compliance for assigned sites.
• Responsible for set-up and maintenance of the site electronic trial master file (eTMF); tracks, collects and files essential documents,
• Assists in the preparation and coordination of site contract and budget process, including cross-functional collaboration with AtriCure’s legal team.
• Conduct site monitoring (qualification, initiation, interim monitoring and close out visits) in accordance with registry SOPs, registry monitoring plan and associated critical variable monitoring plans, to ensure site is adhering to protocol and case completion guidelines, is implementing corrective actions as necessary, and is adhering to applicable regulations and GCP.
• Assists Registry Manager and Registry Specialists in the development of essential study documentation required for site initiation.
• Verify that all research staff and facilities have adequate resources and qualifications and are maintained throughout the course of the study
• Contribute to company’s registry operating procedures.
• Ability to write clear, succinct, and detailed clinical study monitoring and study visit reports.
• Maintains open, positive, and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors to successfully achieve all organizational objectives and milestones.
• Participates in cross-functional project team meetings.
• Contributes to department initiatives and process improvement as applicable.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

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

• Additional duties as assigned

BASIC QUALIFICATIONS:

• Bachelor’s degree in a science or related technical fieldrequired or demonstrated equivalent combination of education, training and experience
• Minimum two years clinical research experience in a cardiology research environment, medical device trial experience required
• Comprehensive knowledge of ISO, GCP, ICH, FDA and other applicable regulations governing the conduct of clinical trials
• Knowledge and experience in clinical trial monitoring and auditing
• Ability to manage role/responsibility independently.
• Excellent planning, analytical, and problem-solving skills.
• 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.
• Proficiency with Microsoft Office, electronic data capture and other computer data acquisition, data analysis, graphing and plotting results and report writing.
• Ability to travel 15% as required.
• Abilities to work with cross-functional teams

PREFERRED QUALIFICATIONS:

• Previous medical device industry experience
• CCRA or CCRP Certification
• Experience with Observational Research

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to pass pre-employment drug screen and background check