Clinical Study Associate I

AtriCure, Inc. provides innovative technologies for the treatment of 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 medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

POSITION SUMMARY:

This position will be a key contributor to AtriCure's clinical affairs department to assist in the development, implementation, and execution of multiple key study functions. The Clinical Study Associate primary responsibilities include but are not limited to supporting device supply logistics, financial processes (contracts, budgets, and invoices), essential document and trial master file (TMF) management and select monitoring activities. The Clinical Associate is a key contributor to AtriCure' s clinical affairs department to assist in the development, implementation, and execution of departmental needs and key study functions. In addition, this position will provide administrative support as needed. The position requires a skilled, professional person who can work well in a matrix team environment and readily adapt as departmental and study needs change over time. Independent judgment is required to plan, prioritize and organize a diversified workload with support/direction from management. Team collaboration and willingness to take on and learn new tasks will also be a key asset critical to success.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Responsible for set-up of the electronic trial master file (eTMF), assists in collection and quality control of documents, files clinical trial documents, and assists in maintenance and ongoing tracking of clinical documents
• Assists team as needed in project coordination efforts, planning and logistics
• Assists team as needed in identification, creation, documentation, and maintenance of processes required for conduct of a clinical trial
• Assists in tracking study activity, such as start-up process by ensuring receipt of proper documentation, agreements, and site approvals
• Assists team as needed in developing, coordinating, managing device processes and logistics from demand planning, device setup in the clinical database, ordering, re-supply and tracking for study sites including quality control and filing of documents
• Facilitates execution of study contracts and budgets (help as needed to move contracts and agreements through the signature process, limited quality control reviews, record keeping associated with executed contracts)
• Collaborates with Clinical Project Manager and Clinical Operations Associate to track accruals, processing and reconciliation of payments
• Assists Clinical Research Associates (CRAs) in performing monitoring preparation activities and potentially assist in select monitoring activities at local investigational sites
• Create, run and monitor metrics and maintenance reports on an ongoing basis
• Assists teams with meeting logistics and planning (including arranging meeting rooms, scheduling teleconferences, preparing and distributing meeting agendas, record, prepare and distribute meeting minutes as needed)
• Assist with clinical trial materials management (may include ordering, copying, creating tabs, building binders, review binder content, shipping, and tracking of documents associated with department or study supplies and study devices)
• Supports clinical teams to create and distribute study newsletters and communications to sites
• Participate in project team meetings and other departmental development initiatives (e.g. training, Standard Operating Procedure (SOP) development process/updates)

Support process improvement efforts to enhance systems and timelines Solves problems of moderate scope and complexity following established policies and procedures Works under general supervision

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 with direction from manager
• Ability to work collaboratively with a cross-functional team
• Additional duties as assigned

BASIC QUALIFICATIONS:

• High school degree or equivalent
• 1-3 years of relative experience
• Proficient with MS Word, MS Excel, and PowerPoint
• Strong attention to detail
• Excellent written and verbal communication skills
• Excellent organizational and time management skills
• Understanding of the administrative aspects of document management
• Ability to effectively manage/prioritize multiple projects
• Ability to create and manage internal and external partnerships
• Experience working in clinical trial master files/databases
• Problem solving/troubleshooting experience
• Basic knowledge of Good Clinical Practices and regulatory compliance for clinical trials
• Ability to respond flexibly and positively under conditions of uncertainty or change

PREFERRED QUALIFICATIONS:

• Bachelors degree preferred
• Experience in the medical device or pharmaceutical industry desired but not required
• Flexibility and willingness to learn new skills, processes, and computer systems
• Clinical Research Organization (CRO) experience desired

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Occasionally lift up to 25 pounds
• Ability to pass pre-employment drug screen and background check

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AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits. AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).