Job Description

Job Overview

The Clinical Trial Assistant (CTA) is responsible for supporting the conduct of clinical trials and handling administrative aspects of clinical trial execution. This role will support the Clinical Project Managers with completion of all study deliverables, ensuring the highest level of data quality; proactively identifies, communicates, and resolves clinical study operational issues; and participates in process improvement initiatives as required.

Job Duties and Responsibilities

· Completion of general administrative tasks to support team members with clinical trial execution, e.g., development and formatting of documents, review and reconciliation of study- specific information, etc.

· Maintains study status updates

· Tracks, prepares and reports study-specific information using databases, spreadsheets, and other tools

· Drafts and reviews study documents, including essential document packets, study plans/manuals, templates, informed consent forms, etc.

· Manages clinical and non-clinical supplies, including purchase and shipping, if needed

· Develops and distributes electronic site file documents

· Schedules/coordinates meetings, takes and distributes meeting minutes

• Tracks and maintains Action, Decision and Issue logs; ensuring follow up with team members for completion
• Supports oversight of vendors and adherence to study plans (e.g., tracking Monitoring Visit schedules, review of reports, resolution of issues)

· Support overall quality, maintenance, and completeness of Trial Master Files

• Develop and maintain study team lists

· Performs other duties as assigned

Key Core Competencies

• Knowledge of regulatory and compliance requirements for clinical research
• Knowledge and experience with Trial Master Files (TMF) and experience with electronic TMF systems
• Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands.
• Excellent communication and interpersonal skills are essential as the CTA interacts with many people of varying levels of responsibility for clinical trial programs
• Ability to collaborate effectively with internal and external study management teams to meet project timelines
• Ability to prioritize and complete tasks according to deadline.
• Problem solving study-related issues; demonstrating resourcefulness, independence and appropriate escalation of issues as needed
• Excellent writing skills to assist with creation of file notes, team communications, and other documents as assigned.
• Strong computer skills in MS Office including (Word, Excel, PowerPoint), MS Project, and other applicable applications.

Education and Experience

• Bachelor’s degree or equivalent curriculum (scientific or healthcare discipline preferred)
• A minimum of 2 years of relevant experience is preferred

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