Clinical Trial Associate

Overview

• Support clinical trial teams with administrative and project tracking tasks to ensure effective trial execution and compliance with regulations.
• Collaborate with cross-functional teams to manage site start-up through close-out activities adhering to SOPs and guidelines.
• Maintain and format essential trial documents, ensuring accuracy and completeness in the Trial Master File (TMF).
• Utilize databases and tools to track study-specific information and maintain dashboards for trial monitoring.
• Coordinate meetings, author and distribute minutes, and maintain study team lists for streamlined communication.
• Support vendor management and communication for specific tasks as directed by the study team.
• Participate in TMF completeness reviews and assist with records management to ensure compliance.
• Contribute to the reconciliation of study-specific information and support dashboard accuracy.

Key Responsibilities & Duties

• Assist in the development and maintenance of trial documents, ensuring adherence to regulatory standards.
• Perform administrative tasks such as meeting coordination, minutes distribution, and study team list updates.
• Maintain essential documents lists and participate in TMF completeness reviews to ensure trial compliance.
• Track and maintain study-specific information using CTMS systems and other tools.
• Support communication and information tracking between study teams, sites, and vendors.
• Collaborate with Records Management to ensure proper filing and maintenance of trial documents.
• Assist in vendor management tasks and maintain effective communication for trial operations.
• Provide administrative support for clinical trial execution, adhering to SOPs and applicable regulations.

Job Requirements

• Bachelor’s degree in a scientific or healthcare discipline or equivalent curriculum required.
• Relevant research experience recommended; entry-level candidates are encouraged to apply.
• Proficiency in maintaining positive relationships with management and peers.
• Ability to travel approximately 10% for trial-related activities.
• Strong organizational skills for managing trial documents and information tracking.
• Experience with CTMS systems and tools for trial monitoring is advantageous.
• Knowledge of clinical trial regulations and SOPs preferred.
• Effective communication skills for vendor coordination and team collaboration.