Clinical Trial Specialist

Overview

• Provide logistical support for clinical trials, ensuring compliance with SOPs and regulations.
• Collaborate with cross-functional teams to manage site start-up and close-out activities.
• Maintain and review study documents, including site instructions and manuals.
• Set up and utilize trackers, dashboards, and reports to monitor study metrics.
• Manage small-scope vendors and support complex vendor operations.
• Oversee vendor contracts, invoicing, and forecasting with study lead oversight.
• File and maintain study documents in the electronic Trial Master File (TMF).
• Contribute to team meetings and provide input on study management activities.

Key Responsibilities & Duties

• Develop, review, and maintain study documents such as manuals and instructions.
• Set up and maintain tools, trackers, and dashboards to support clinical trials.
• Manage vendors, including contracts, invoicing, and purchase order monitoring.
• Coordinate site management responsibilities and ensure compliance with protocols.
• File essential study documents and participate in TMF completeness reviews.
• Serve as the main study contact for Records Management activities.
• Contribute to Study Management Team meetings and provide relevant content.
• Support study lead oversight and vendor management tasks.

Job Requirements

• Bachelor’s degree in a scientific or healthcare discipline preferred.
• Minimum of two years of direct experience in clinical research.
• Understanding of study phases and their application to clinical development.
• Ability to manage multiple tasks and deadlines effectively.
• Self-motivated with problem-solving skills for moderate scope and complexity.
• Strong interpersonal skills to build and maintain positive relationships.
• Willingness to travel up to 10% as required.
• Proficiency in managing study documents and electronic filing systems.