AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator® Synergy™ Ablation System is the first and only medical device to receive FDA approval for the treatment of long standing persistent Afib. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
This position will support, development, and supervise implementation and execution of study protocols for clinical studies and marketing studies, with primary emphasis on study management of IDE clinical studies. Assist with the development of clinical study strategies and investigational plans (protocol, case report forms, consents, instructions for use, hospital contracts, etc.). Support team for regulatory filings and new product development projects as needed. Plan, coordinate, and implement study/device training and investigator/clinical coordinator meetings. Provide feedback to/from sites regarding improvements to technology/procedures. Develop and maintain standard operating procedures (SOP) related to clinical studies. Supervise and support clinical affairs personnel. Oversee activities of Contract Research Organizations (CROs) and Study Core Labs. Perform/oversee study closure activities. Organize and direct investigator conferences to review findings and advise on study direction, as needed. Oversee daily activities related to the clinical department and clinical studies from study/site identification to closure (i.e. site selection, IRB approvals, monitoring/supervision, etc.) for applicable studies.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Assists the VP Clinical Affairs and Biometrics with the implementation of clinical affairs policies, programs, and procedures.
- Leads and organizes clinical studies.
- Provides project direction for clinical study projects.
- Prepares study documentation for investigational studies and sites.
- Prepares budget requirements for study budgets.
- Negotiates clinical research agreements.
- Create and maintain study files.
- Uses databases (or equivalent) to track and maintain site information, device inventory, regulatory documentation, subject enrollment, and other information as required.
- Participates in data management activities for studies.
- Prepares study related status reports as required.
- Provides input into the Clinical Study Protocols and Clinical Study Reports.
- Coordinates and/or participates in Study Coordinator and Principal Investigator conference calls and other meetings as required.
- Attends project team meetings and other meetings as necessary.
- Coordinates archiving of study documents for completed clinical studies.
- Assists with preparation of IDE reports and study related publications as required.
- May serve as the Clinical Affairs representative on cross-functional teams.
- Completes other tasks and projects as assigned by the VP Clinical Affairs and Biometrics.
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- Regular and predictable worksite attendance
- 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
- Graduate degree required or demonstrated equivalent combination of education, training and experience.
- A minimum of 10 years' experience in organizing and managing clinical studies.
- Experience in medical device industry and knowledge of regulations is required.
- Broad knowledge of other clinical operations roles: Data Management; Statistics; Statistical Programming; Medical Writing; Safety Reporting.
- Strong scientific background and/or work experience in medicine, biology, or a closely related field.
- Ability to work independently.
- Demonstrated maturity and leadership ability.
- High degree of self-motivation, direction, ability to make decisions and accept responsibility of outcomes.
- Strong communication skills, both written and oral.
- Strong understanding of the administrative aspects of document management.
- Team oriented and able to effectively manage & prioritize multiple projects.
- General knowledge of medical terminology.
- Excellent organizational & computer skills (word processing, spreadsheets, databases)
- Ability to travel 25% dependent on number of on-going projects.
- Ability to regularly walk, sit, or stand as required
- Ability to occasionally bend and push/pull
- Ability to regularly lift up to 25 pounds, occasionally lift up to 25 pounds
- Ability to pass pre-employment drug screen and background check
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