Clinical Research Assoc, Sr.

Job Description

Responsible for coordinating clinical research activities in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations, and MicroVention SOPs. Job duties :

• As a contributing member on project teams, assist in the implementation of controlled clinical studies of MicroVention products.
• Understand, read, and prepare technical documentation including, informed consents, study forms, and study training documents.
• Responsible for collecting and reviewing site regulatory documents.
• Manage device accountability process.
• Conduct Site Initiation Visits and Closure Visits at clinical study sites.
• Interface with monitors / CROs to address and resolve queries.
• Work closely with Project Manager(s) to ensure clinical studies are conducted in accordance with the protocol, GCP, MicroVention SOPs, and all applicable regulations (e.g., FDA).
• Support budget and contract negotiations with clinical sites.
• Assist in writing clinical study reports by reviewing tables and listings generated from study data.
• 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.

Qualifications

Desired Qualifications