Senior Registry Specialist

AtriCure•Minneapolis, MN

About The Position

POSITION SUMMARY: The Senior Registry Specialist will lead and manage the daily activities for one or more AtriCure sponsored Registries and Registry projects in support of strategic real-world evidence (RWE) initiatives to meet company goals. 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: Supports development and management of Registry and Registry Projects in alignment with the strategic business needs, such as but not limited to the Regulatory submissions, Publications to support Reimbursement, Claims, and Marketing Statements, Develops and updates the Registry protocol, Case Report Forms (CRF), Informed Consent Forms (ICF), and other documentation to align with strategic needs and steering committee guidance. Assist with Registry data usage projects, including relevance assessments and preliminary data analysis, supporting ongoing AtriCure RWE initiatives. Collaborate cross-functionally to maintain timely and accurate communication with site staff, drive and meet activation and enrollment targets, and resolve site-related issues (e.g., data queries, compliance, enrollment, and activation barriers) Lead Registry Core Team meetings and participate in Registry Steering Committee meetings, document meeting minutes, and follow up on the action items. Work with AtriCure’s Legal, Compliance, and Clinical Operations teams to address contract and budget escalations as needed. Maintain Registry budget and collaborate with AtriCure Finance team on monthly spending and quarterly forecasts. Liaise with the AtriCure Data Management team and external vendors on database builds data migrations, and ongoing database maintenance activities. Assist Registry Manager with site/investigator recruitment, outreach activities, and intro call follow-up. Lead Registry Site Initiation Visit (SIV) and maintain site personnel access within the registry database. Maintain Registry Clinicaltrials.gov updates and study-level central Institutional Review Board (IRB) approvals Standard Operating Procedure (SOP), Work Instructions (WI), and Registry template development and maintenance Liaison with vendors and internal stakeholders on Registry data analysis and data monitoring plan. Ensure Registry documentation and Trial Master File (TMF) are in an audit-ready state Provide input on the project budget and strategic plan. Facilitate the preparation of project and study newsletters, correspondence, study documents, and progress reports ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable work performanceAbility 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

Requirements

Bachelor’s degree with at least 5 years of experience in clinical research (medical device experience preferred).
Strong understanding and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
Basic data analysis skills (Excel Pivot Tables, Python, Power BI etc.)
Ability to multitask, prioritize and meet deadlines in a fast-paced environment
Collaborative approach in working with cross functional teams
Ability to write and communicate professionally with minimal input
Excellent interpersonal communication skills
Ability to travel approximately 10%

Nice To Haves

Experience in the domain of cardiac arrhythmia

Responsibilities

Supports development and management of Registry and Registry Projects in alignment with the strategic business needs, such as but not limited to the Regulatory submissions, Publications to support Reimbursement, Claims, and Marketing Statements
Develops and updates the Registry protocol, Case Report Forms (CRF), Informed Consent Forms (ICF), and other documentation to align with strategic needs and steering committee guidance.
Assist with Registry data usage projects, including relevance assessments and preliminary data analysis, supporting ongoing AtriCure RWE initiatives.
Collaborate cross-functionally to maintain timely and accurate communication with site staff, drive and meet activation and enrollment targets, and resolve site-related issues (e.g., data queries, compliance, enrollment, and activation barriers)
Lead Registry Core Team meetings and participate in Registry Steering Committee meetings, document meeting minutes, and follow up on the action items.
Work with AtriCure’s Legal, Compliance, and Clinical Operations teams to address contract and budget escalations as needed.
Maintain Registry budget and collaborate with AtriCure Finance team on monthly spending and quarterly forecasts.
Liaise with the AtriCure Data Management team and external vendors on database builds data migrations, and ongoing database maintenance activities.
Assist Registry Manager with site/investigator recruitment, outreach activities, and intro call follow-up.
Lead Registry Site Initiation Visit (SIV) and maintain site personnel access within the registry database.
Maintain Registry Clinicaltrials.gov updates and study-level central Institutional Review Board (IRB) approvals Standard Operating Procedure (SOP), Work Instructions (WI), and Registry template development and maintenance
Liaison with vendors and internal stakeholders on Registry data analysis and data monitoring plan.
Ensure Registry documentation and Trial Master File (TMF) are in an audit-ready state
Provide input on the project budget and strategic plan.
Facilitate the preparation of project and study newsletters, correspondence, study documents, and progress reports
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