Terumo Neuro · 5 hours ago
Associate II, Field Clinical Monitoring (U.S. Remote)
United States
Full-time
Remote
Mid Level
$92K/yr - $115K/yr
4+ years expTerumo Neuro is a company focused on clinical research and medical devices, and they are seeking an Associate II for Field Clinical Monitoring. The role involves ensuring compliance with study protocols and regulations, facilitating communication among stakeholders, and overseeing site operations to maintain data integrity and quality.
Medical Device
Responsibilities
Identify, develop, and maintain investigators and sites capable of delivering start-up goals, enrollment targets, and required data quality
Facilitate and maintain open communication among investigational sites, study and data management teams, and the company. Ensure effective communication with key stakeholders
Work closely with Project Manager(s) to ensure clinical studies are conducted in accordance with the protocol, GCP, company SOPs, and all applicable regulations (e.g., FDA)
Understand, read, and deploy study documentation including informed consents, study forms, and study training documents
Responsible for collecting and reviewing essential documents, facilitating necessary corrections, and filing in assigned system(s)
Maintain device accountability records
Review data and source documentation from investigational sites for accuracy and completeness; facilitate resolution of data queries and manage action items to completion
Conduct and perform site initiation visits, site training, interim monitoring visits, and close-out visits
Maintain accurate, detailed, and complete records of monitoring visits and reporting findings according to plans and processes
Collaborate with sites to ensure adherence to compliance requirements and escalate non-compliance when necessary
Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
Perform additional duties as assigned
Qualification
Required
Bachelor's degree in a related field of study, preferably in Life Science, or equivalent combination of education and experience
Minimum four (4) years of medical device monitoring experience
Minimum two (2) years of neurovascular experience
Strong knowledge of FDA regulations for clinical trials and clinical procedures
Ability to travel M-F, 4 weeks a month (75%-100%)
Strong collaborative skills with demonstrated ability to work with physicians, site coordinators, and others within the company
Experience using technologies for clinical research (electronic data capture and clinical trial management systems)
Excellent written and verbal communication skills, including computer literacy
Strong computer skills including MS Office (e.g., Word, Excel, Access, PowerPoint, Outlook, Teams, etc.)
Preferred
Proven clinical research expertise in various therapeutic areas
Experience in a catheter lab environment
Company
Terumo Neuro
We’re in business to create and deliver innovations that redefine what’s possible in neurovascular treatment, meaningfully advancing both physician practice and patient outcomes.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase