Clinical Trial Associate

Overview

• Provide administrative and project tracking support for clinical trial teams, ensuring compliance with SOPs and regulations.
• Collaborate with cross-functional teams to manage site start-up through close-out activities effectively.
• Assist in developing, maintaining, and distributing trial-related documents and study-specific information.
• Coordinate meetings, author and distribute minutes, and maintain study team lists.
• Manage electronic Trial Master File (TMF) and ensure completeness of essential study documents.
• Utilize databases and tools to track and maintain study-specific information and dashboards.
• Support communication and information tracking between study teams, sites, and vendors.
• Participate in vendor management and coordination tasks as required.

Key Responsibilities & Duties

• Assist with the development, formatting, and distribution of clinical trial documents.
• Maintain and reconcile study-specific information and essential document lists.
• Coordinate meetings, prepare agendas, and distribute meeting minutes.
• Organize and manage electronic Trial Master File (TMF) for study documentation.
• Track and update dashboards and databases for clinical trial progress.
• Support communication and coordination between study teams, sites, and vendors.
• Participate in vendor management and ensure adherence to study protocols.
• Ensure compliance with regulatory requirements and Standard Operating Procedures (SOPs).

Job Requirements

• Bachelor’s degree in a scientific or healthcare discipline is required.
• Relevant research experience is recommended but not mandatory.
• Strong ability to build and maintain positive relationships with peers and management.
• Proficiency in utilizing databases, spreadsheets, and clinical trial management systems.
• Excellent organizational skills and attention to detail.
• Ability to travel approximately 10% as required.
• Familiarity with regulatory requirements and clinical trial processes.
• Capability to manage multiple tasks and prioritize effectively in a remote work environment.