Asociado Senior de Investigación Clínica

<div class="content-intro"><p style="margin: 0in; text-align: justify; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-size: 10.0pt; font-family: Arial, sans-serif;">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.</span></p> <p style="margin: 0in; text-align: justify; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;">&nbsp;</p> <p style="margin: 0in; text-align: justify; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-size: 10.0pt; font-family: Arial, sans-serif;">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.</span></p></div><p></p> <p style="margin: 0in 20.7pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black;">POSITION SUMMARY:</span></p> <p style="margin: 0in 20.7pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black; ">The Senior Clinical Research Associate (Sr. CRA) at AtriCure plays a vital role in the Clinical Affairs department, independently managing and overseeing site management and/or monitoring activities during clinical trial execution. This position requires a high level of autonomy and leadership, providing guidance to junior team members and ensuring compliance with regulatory standards and protocols. The Sr. CRA is instrumental in maintaining the integrity of clinical data and adapting to evolving study needs.</span></p> <p style="margin: 0in 20.7pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;">&nbsp;</p> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black; ">ESSENTIAL FUNCTIONS OF THE POSITION:</span></p> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black; ">Site Management</span></p> <ul style="margin-top: 0in; margin-bottom: .0001pt;"> <li style="margin: 0in 20.7pt 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black;">Coordinate the collection and review of essential documents from clinical investigation sites in collaboration with study team personnel.</span></li> <li style="margin: 0in 20.7pt 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black;">Conduct Site Qualification, Initiation, Interim and Close-Out training visits.</span></li> <li style="margin: 0in 20.7pt 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black;">Facilitate required training sessions (e.g., EDC, Protocol, Device) and support site nomination and qualification processes.</span></li> </ul> <p style="margin: 0in 20.7pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;">&nbsp;</p> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black; ">Site Communications</span></p> <ul style="margin-top: 0in; margin-bottom: .0001pt;"> <li style="margin: 0in 20.7pt 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black;">Act as the primary point of contact for site communications and inquiries.</span></li> <li style="margin: 0in 20.7pt 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black;">Liaise with clinical study management, field personnel, and CROs, addressing moderately complex protocol or study related issues as necessary.</span></li> </ul> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;">&nbsp;</p> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black; ">Compliance</span></p> <ul style="margin-top: 0in; margin-bottom: .0001pt;"> <li style="margin: 0in 20.7pt 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black;">Ensure clinical study sites adhere to assigned protocols and regulatory standards, independently reviewing individual site compliance and addressing issues with study management.</span></li> </ul> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;">&nbsp;</p> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black; ">Data Management</span></p> <ul style="margin-top: 0in; margin-bottom: .0001pt;"> <li style="margin: 0in 20.7pt 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black;">Review and analyze data for accuracy and completeness.</span></li> <li style="margin: 0in 20.7pt 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black;">Lead the creation, management, and resolution of data queries for assigned sites</span></li> <li style="margin: 0in 20.7pt 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black;">Support development of data cleaning reports and metrics in collaboration with data and operations management teams.</span></li> </ul> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;">&nbsp;</p> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black; ">Monitoring</span></p> <ul style="margin-top: 0in; margin-bottom: .0001pt;"> <li style="margin: 0in 0in 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt;">Conduct site monitoring visits (qualification, initiation, interim, and close-out) to ensure adherence to study procedures and regulatory requirements.</span></li> <li style="margin: 0in 0in 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt;">Assist in reviewing peer interim monitoring visit (IMV) reports.</span></li> </ul> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;">&nbsp;</p> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black; ">Safety</span></p> <ul style="margin-top: 0in; margin-bottom: .0001pt;"> <li style="margin: 0in 0in 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt;">Manage the processing of product complaints and adverse events, collaborating with safety specialists to gather materials for CEC meetings.</span></li> </ul> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;">&nbsp;</p> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black; ">Study Management</span></p> <ul style="margin-top: 0in; margin-bottom: .0001pt;"> <li style="margin: 0in 0in 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt;">Draft study-related materials, such as patient brochures and recruitment tools.</span></li> <li style="margin: 0in 0in 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt;">Support the coordination of activities with study-specific committees, vendor services, and core labs.</span></li> </ul> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;">&nbsp;</p> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black; ">Leadership and Development</span></p> <ul style="margin-top: 0in; margin-bottom: .0001pt;"> <li style="margin: 0in 0in 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt;">Provide mentorship and guidance to junior team members, fostering a collaborative environment.</span></li> <li style="margin: 0in 0in 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt;">Engage in continuous professional development and contribute to strategic project management activities.</span></li> </ul> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;">&nbsp;</p> <p style="margin: 0in 20.9pt 0.0001pt 13.5pt; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt; color: black; ">Other Duties</span></p> <ul style="margin-top: 0in; margin-bottom: .0001pt;"> <li style="margin: 0in 0in 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt;">Ensure appropriate translations for study documents and engage in global process improvement initiatives.</span></li> <li style="margin: 0in 0in 0.0001pt 0px; text-align: justify; line-height: normal; font-size: 11pt; font-family: Arial, sans-serif;"><span style="font-size: 10.0pt;">Mentor less experienced clinical team members and participate in core team activiti