Job Title: Clinical Trial Associate

Work Location: Remote

Summary:

The Clinical Trial Associate will provide essential administrative and project tracking support to clinical trial teams, ensuring all activities from site start-up through close-out are conducted in compliance with relevant procedures and regulations. This role involves collaboration with cross-functional teams and external partners to maintain accurate documentation and support the successful execution of clinical studies.

Responsibilities:

• Support clinical trial execution by managing document development, formatting, distribution, and maintaining study team lists.
• Organize and maintain study documents and correspondence in the electronic Trial Master File (TMF), ensuring completeness and accuracy.
• Conduct regular reviews of essential documents and participate in TMF completeness checks.
• Track and update study-specific information using databases, spreadsheets, and clinical trial management systems (CTMS).
• Coordinate and document meetings, including scheduling, agenda preparation, and authoring meeting minutes.
• Facilitate communication and information flow between study teams, sites, and vendors, including contract research organizations (CROs).
• Assist with administrative and project tracking tasks to support overall clinical trial progress.
• Collaborate with cross-functional teams and support vendor management activities as needed.

Qualifications:

• Bachelor’s degree required, preferably in a scientific or healthcare discipline.
• No previous experience required; relevant research experience is recommended.
• Strong organizational and communication skills with the ability to build and maintain positive relationships with peers and management.
• Experience with Trial Master File (TMF) management, document filing, and completeness reviews is beneficial.
• Familiarity with clinical trial management systems (CTMS) is preferred.
• Ability to coordinate meetings and author meeting minutes.
• Experience supporting site start-up through close-out activities is advantageous.
• Willingness to travel approximately 10% as required.

Published Category: Clinical Operations & Development