Job Summary
The Clinical Support Specialist II (CSS II) plays an advanced and independent role in clinical trial execution by maintaining relationships with clinical trial sites from selection through enrollment across the U.S. and globally. Building on established expertise, the CSS II actively leads recruitment and qualification efforts at the site level, supports patient recruitment and enrollment at sites, ensures rigorous protocol adherence, patient safety, and optimal procedural outcomes during case support. Additionally, the CSS II serves as an internal resource providing clinical insights on protocols, assisting with advanced training in disease states and therapeutic areas, analyzing core lab data, and ensuring the accuracy of clinical data entry.
Job Details/Responsibilities
- Provides input as a clinical SME on key study documents, including Protocols, study plans, Investigational Brochures, and Information for Use, to support study success and ensure quality outcomes.
- Supports the development of and compliance to study specific Clinical Support Plans (CSP), Investigational Product Management Plan (IPMP), Clinical Training Plan, and other study plans as assigned.
- Assists in identifying and assessing potential clinical investigators for clinical study participation, managing sites through feasibility, qualification, and site selection.
- Supports study activities at the site, including site selection, Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), procedural support including protocol eligibility, query resolution, and ensuring accuracy and timeliness in core-lab imaging requirements, including upload processes.
- Assists in development & implementation of CSS and Physician device training/certification programs for assigned clinical studies.
- Provides clinical and technical support to 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 guidance with Terumo products, reporting device complaints when appropriate, within company guidelines.
- Develops and implements 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, ordering, and additional site metrics as needed.
- Assists in the collection, analysis, and interpretation of clinical data, gaining valuable insights to drive continuous improvement in study data accuracy and compliance with protocols.
- Contributes to the development and refinement of disease state training materials to strengthen internal team expertise, ensuring effective support for investigational product clinical studies and procedures.
- Collaborates 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.
- Leads monitoring and tracking of strict medical device transaction accountability at the site and study level to ensure accurate fulfillment and consumption of investigational products. This includes completing timely quarterly investigational product reports for required study compliance.
- Completes and tracks progress of device Product Performance Reports (PPR) according to department procedures and supports internal device evaluations initiatives.
- Executes accurate and timely clinical study deliverables with increasing independence while providing support to junior staff as needed, and for presenting periodic status reports on assigned clinical studies during regular team meetings and stakeholder meetings.
- Supports the development, refinement, and implementation of Standard Operating Procedures (SOPs), tracking systems, and tools designed to optimize workflows and improve organizational effectiveness within TMC and other Terumo Entities.
Job Responsibilities (continued)
- Contributes to the design, development, and delivery of training programs and modules that align with global commercialization strategies, ensuring alignment with the department Director’s directives.
- Supports pre-clinical, pre-market, and post-approval initiatives by managing tasks such as data review, maintaining accurate documentation, and coordinating enrollment efforts, ensuring compliance with project requirements.
- Exhibits flexibility and takes initiative in supporting departmental projects and initiatives, contributing effectively during and between studies, as required.
- Demonstrates a commitment to patient safety and product quality by maintaining compliance with all TMC Quality Systems requirements. This includes but is not limited to the prompt recognition and forwarding of customer complaints (i.e. adverse events, product performance reports, etc.) to Quality Assurance (QA), and by ensuring all promotional messaging (i.e. branding strategies, product claims, etc.) and materials (i.e. literature) discussed or presented to customers are clinically accurate and adhere to AdvaMed guidelines and Terumo’s policy on Interactions with Healthcare Professionals. Maintain strong knowledge of and adherence to regulations regarding promotional material content and control. Follow procedures for good clinical practices (GCP) and Design Control when participating in new product development and clinical activities. Fully adhere to all applicable FDA regulations, international guidelines and Terumo’s policies at all times.
Working Conditions/Physical Requirements
- This is a field-based position. Must be able to drive personal automobile on a daily basis to/from customer accounts and drive long distances as necessary.
- This position requires approximately 70% overnight travel. In addition, occasional weekend and international travel is required.
- Daily entry to hospitals and other medical facilities is required. Many facilities have instituted vendor credentialing policies which require vendors to meet defined training, background check and proof of immunization requirements as a condition of entry. Terumo Associates entering these facilities are required to abide by these credentialing requirements.
- Must be able to gain access to and work in the IR suite, cath lab and operating room. Entry into these areas requires an ability to wear appropriate gowning, stand for long periods of time, comply with hospital policy/protocol and be aware of potential biohazards such as blood borne pathogens.
- A reliable internet connection and dedicated workspace for remote work are required.
- This field-based position requires the ability to work independently, maintaining productivity and efficiency with minimal supervision, both from a home office and on-site.
Knowledge, Skills and Abilities (KSA)
- Advanced clinical knowledge base in anatomy, physiology, neurovascular, and/or cardiology/interventional procedures and terminology.
- Comprehensive understanding of angiographic imaging and case progression.
- Ability to develop strong relationships 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 create and deliver group presentations.
- Ability to interact and collaborate effectively 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 and analyze 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, 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.
- Demonstrated understanding of FDA regulations and clinical trial processes,
Qualifications/ Background Experiences
- Bachelor’s degree required(Biology, Chemistry, Sports Medicine, Nursing, Engineering, or Health Sciences field strongly preferred) and minimum of 3 years interactive scrub experience in an interventional cath, vascular, or radiology lab and 2 years’ experience in a clinical role in either medical device or device use within a clinical setting or equivalent combination of education, training and relevant experience.
- Practical experience in supporting or managing clinical research activities in a regulated environment required.
