Clinical Research Assoc, Sr.
Terumo Neuro
Date: 2 weeks ago
City: Aliso Viejo, CA
Contract type: Full time
Job Description
Responsible for coordinating clinical research activities in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations, and MicroVention SOPs. Job duties:
US - United States
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.
- Bachelor’s degree or equivalent combination of education and experience in related field.
- Minimum six (6) years of direct clinical research experience, preferably in the medical device industry, including at least two (2) years of monitoring experience.
- 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.
- Proficient computer skills including MS Office (e.g., Word, Excel, Access, PowerPoint, Outlook, Teams, etc.).
- Bachelor’s degree in Life Science preferred.
- Clinical research expertise in various therapeutic areas (preferred areas: Neurovascular and/or Cardiovascular).
- Experience in the medical device industry.
- At least two (2) years of project management experience.
US - United States
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