Job Summary
The Senior Clinical Support Specialist - Aortic (Sr. CSS) is instrumental in clinical trial execution, bringing extensive expertise in managing clinical trial site relationships from selection through enrollment on a national and global scale. As a seasoned subject matter expert (SME) in the aortic disease state, the Sr. CSS manages site recruitment and qualification, drives patient recruitment and enrollment strategies at the study level, and ensures high standards in protocol adherence, patient safety, and procedural outcomes during case support.
The Sr. CSS - Aortic assumes a mentorship role within the Clinical Support team, providing strategic direction, and expertise in the planning and execution of clinical research programs.
Job Details/Responsibilities
- Manages study activities at the site, including oversight of site selection, Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), expert-level procedural support including pre-case planning, protocol eligibility, query resolution, and ensures the accuracy and timely execution of core-lab imaging requirements, including uploads.
- Develops and maintains study specific Clinical Support Plans (CSP), Investigational Product Management Plan (IPMP), Clinical Training Plan, and others study plans as assigned and secures compliance to plans across team members.
- Trusted clinical advisor to aortic Investigators and research staff, ensuring strict adherence to protocol, including eligibility during case support, regulatory compliance, and the efficient conduct of study operations, as well as providing technical assistance with Terumo products, reporting device complaints when appropriate, within company guidelines.
- Provides input on key study documents, including protocols, study plans, Investigational Brochures, and Information for Use to drive successful outcomes as a clinical SME for the aortic disease state.
- Develops and manages tools to track and analyze trends at sites and across the study including site-specific recruitment, patient screening and enrollment metrics, investigational device use/errors, and identifies additional study specific trends that may require evaluation and/or mitigation.
- Mentors and Facilitates collaboration with cross-functional teams to ensure adherence to study protocols, regulatory guidelines, and industry standards throughout the duration of clinical trials, including GCP, ICH, and FDA guidelines.
- Maintains oversight of strict medical device transaction accountability at the site and study level to ensure accurate fulfillment and consumption of investigational products. This includes ownership and mentoring of team members.
Knowledge, Skills and Abilities (KSA)
- Exceptional clinical knowledge base in anatomy, physiology, aortic, neurovascular, and cardiology/interventional procedures and terminology.
- Comprehensive understanding of angiographic imaging and aortic case progression.
- Ability to review CT imaging for educational and procedural support purposes in aortic disease–focused clinical studies.
- Ability to develop strong relationships in a highly trusted role with investigator base including study coordinators, physicians, and cath lab staff.
- Strong communication and interpersonal skills to demonstrate products and procedures clearly and succinctly.
- Ability to lead the creation and delivery of impactful presentations to high-level stakeholders and mentors others in presentation techniques.
- Ability to proactively facilitate collaboration with cross-functional groups, especially R&D, clinical and marketing, to represent the investigator perspective on product enhancements and new product development.
- Ability to interpret, analyze, and effectively address clinical data.
- Ability to prioritize tasks and exercise judgment to work independently and effectively as a remote team member.
- Ability to demonstrate a proactive approach to problem-solving, identifying and addressing challenges as they arise to ensure timely resolution and minimize impact on study timelines and objectives.
- Ability to take ownership of assigned tasks and projects, demonstrating the ability to work independently and efficiently while also seeking guidance and support when needed.
- Attention to detail, analytical thinking, and a commitment to delivering high-quality work in a fast-paced environment.
- Comprehensive knowledge of FDA regulations, clinical trial processes, and industry best practices, developed through extensive experience in clinical research
Qualifications/ Background Experiences
- Bachelor’s degree required (Biology, Chemistry, Sports Medicine, Nursing, Engineering, or Health Sciences field strongly preferred). Minimum of 5 years interactive scrub experience in an interventional cath, vascular, or radiology lab performing high volume aortic interventional procedures or 5 years supporting interventional aortic devices in an industry role required. 2 years’ experience in a clinical role in either medical device or device use within a clinical setting required or equivalent combination of education, training and relevant experience.
- Practical experience in supporting or managing clinical research activities in a regulated environment desired.
