Clinical Study Coordinator
7 days ago
Job Summary
This role supports clinical studies from start-up to close-out, ensuring accurate and complete documentation in accordance with standard operating procedures. The Clinical Study Assistant works closely with Clinical Operation Managers and Clinical Research Associates to track and report clinical trial progress.
Key Responsibilities
- Enter and maintain documentation in study-specific databases, including purchases, contracts, health care compliance, and study document management.
- Set up and maintain the Trial Master File, investigator study file binders, and regulatory document collection.
- Review protocols and study documents for consistency and accuracy.
- Coordinate and plan investigator meetings, site training, and other company functions.
- File and review test article accountability reconciliation forms from study sites.
- Perform other duties as assigned.
Requirements
The ideal candidate will have a Bachelor's degree or higher from an accredited institution and 1-2 years of experience in a Clinical Trial Coordinator I role or 3+ years of related clinical experience. Strong organizational skills and proficiency in Microsoft Office products, including Word, Excel, PowerPoint, Project, and SharePoint, are required. The ability to work independently in a team environment and communicate effectively with all levels of an organization is essential.
Preferred Qualifications
1 year of leadership experience and knowledge of FDA guidelines, regulations, and/or Good Clinical Practice are highly desirable.
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