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MicroVention-Terumo · 5 months ago

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

United States

Full-time

Remote

Mid Level

$92K/yr - $115K/yr

4+ years exp

MicroVention-Terumo is a company focused on clinical operations in the medical device field. They are seeking an Associate II for Field Clinical Monitoring to drive study execution and ensure compliance with clinical protocols and regulations, while maintaining communication with investigational sites and stakeholders.

Health CareManufacturingMedicalNeuroscience

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

Medical device monitoringNeurovascular experienceFDA regulations knowledgeClinical research technologiesCollaborative skillsMS Office proficiencyWritten communicationVerbal communication