Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

The Sr. Field Specialist, Clinical Research provides clinical research case support to physicians within a given territory and provides case support on peripheral and coronary interventional procedures in pre-market and post-market phases of product development with SELUTION-SLR. In this role you are critical to the quality execution of our clinical studies in the coronary and peripheral space.  You will be on site with investigators and research coordinators training on clinical trial protocols and supporting cases as an expert on the clinical protocol and the Selution SLR drug eluting balloon. 

Responsibilities

• Perform Physician and hospital staff training and procedural case coverage to ensure safe and effective use of the device
• Present clinical study training materials based on investigational plans including study protocol, IFU, core lab manuals and case report forms
• Provide field support for clinical studies by participating in site selection, site initiation and activation, supporting cases, ensuring quality data acquisition throughout follow up and performing study closure activities
• Address clinical research site needs by maintaining frequent contact via email/phone/on-site visits with PI's and research coordinators
• Responsible for gaining and maintaining knowledge of clinical sites in a given geographical area to best understand and assess investigators’ interests and capabilities
• Manage key study sites (investigators and research staff) and serve as 'live' point of contact with the site for communication with SELUTION CSM, CRA, and CRO team
• Partner with SELUTION clinical research teammates to meet business needs in the field including site CIP questions, re-training, case coverage, data entry/query resolution and escalation of critical issues
• Administrative activities including evaluating metrics, data entry into trackers, documentation of activities and site feedback to SELUTION study teams
• Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines and policies
• Identify and mitigate quality risks and issues for assigned clinical studies with oversight from study management team
• Assist with oversight of activities performed by CRO
• Maintain in-depth knowledge of current study protocols, process and procedures to assist sites and facilitate study management team efforts

Role Expectations:

• Reside within designated geographic territory to facilitate on-site visits to assigned clinical sites
• Be available to cross-cover sites as back up for other FSCR territories, including holding necessary credentialing
• Attend and lead SIV and site activation activities at assigned sites (in-person priority) for duration of the event
• Attend start-up phase enrollments and clinical follow up visits at each assigned site to ensure site protocol compliance, image upload and readability and quality data collection
• Prioritize regular communication with study management team and CRO

Qualifications

• Bachelor’s Degree in life sciences, nursing, engineering, or healthcare related field (preferred)
• 8+ years’ experience with cardiovascular procedures in clinical research in this same role or as a nurse or tech as radiology tech or Cath Lab tech
• 8+ years’ experience working directly with physicians and healthcare professionals
• Prior experience with clinical trials (preferred)
• Experience in coronary or peripheral interventions
• Experience with Good Clinical Practice (GDP) and/or regulatory compliance guidelines for clinical studies
• Ability to travel (at least 75%) to company and clinical trial sites 

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammate’s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.