Clinical Support Specialist II

Terumo Medical Corporation

Clinical Support Specialist II at Terumo Medical Corporation leading clinical trial execution and patient recruitment, ensuring protocol adherence and providing clinical insights throughout the process.

Posted 6/24/2026full-timeSomerset • New Jersey • 🇺🇸 United StatesMid-LevelSenior💰 $96,400 - $132,550 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.
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.

Requirements

What you’ll need

Bachelor’s degree required (Biology, Chemistry, Sports Medicine, Nursing, Engineering, or Health Sciences field strongly preferred)
minimum of 3 years interactive scrub experience in an interventional cath, vascular, or radiology lab
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

Benefits

Comp & perks

annual bonus
paid vacation
paid holidays
health, dental and vision benefits
401(k), with matching contributions
tax advantage savings accounts
legal plan
voluntary life and AD&D insurance
voluntary long-term disability
short term disability
critical illness and accident insurance
parental leave
personal leave
tuition reimbursement
travel assistance
employee assistance program

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical study designclinical data analysisprotocol developmentregulatory complianceclinical traininginvestigational product managementsite qualificationpatient screeningdevice trainingclinical research activities

Soft Skills

communicationcollaborationleadershipproblem-solvingattention to detailorganizational skillsinterpersonal skillsanalytical thinkingtime managementteam support

Certifications

Bachelor’s degreeclinical research certificationmedical device training certification