Associate II, Field Clinical Monitoring; U.S. Remote

Associate II, Field Clinical Monitoring (U.S. Remote)

Join to apply for the Associate II, Field Clinical Monitoring (U.S. Remote) role at Terumo Neuro
. This remote position offers the opportunity to drive study execution and operational excellence in alignment with ICH Good Clinical Practices, FDA regulations, guidance documents, and company SOPs.

Responsible for ensuring site compliance with study protocols, informed consent procedures, and data integrity requirements. Provide oversight of site operations, including initiating, monitoring, and closing out study visits, and maintain accurate, detailed records of all monitoring activities.

• 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.
• 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 training documents.
• Collect and review essential documents, facilitate necessary corrections, and file 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 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 demonstrate ethics and integrity in all matters.
• Perform additional duties as assigned.

$91,629 – $114,536. Financial compensation packages may be higher or lower than the listed amount and will ultimately depend on factors including relevant experience, internal equity, skill set, knowledge, geography, education, business needs, and market demand.

• Bachelor’s degree in a related field of study, preferably in Life Science, or an 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.
• 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).

• Proven clinical research expertise in various therapeutic areas.
• Experience in a catheter lab environment.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status, or any other characteristics protected by law.

Terumo Neuro will consider qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.