Clinical Trial Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver extensive administrative and operational assistance to the Clinical Operations Team.

• Offer general administrative support to both the Clinical Operations and Project Management Departments.

• Aid Clinical Operations teams with the ongoing execution of studies and necessary project tasks.

• Organize internal and external meetings, prepare agendas, and produce meeting minutes.

• Facilitate outreach to potential clinical trial sites and manage initial site feasibility assessments.

• Oversee quarterly documentation and compliance reviews using internal trackers and the eQMS system.

• Serve as a super user for the electronic Trial Master File system and monitor eTMF progress.

• Develop professional slide presentations for both internal and external stakeholders.

• Establish, collect, register, organize, and maintain clinical study documentation.

• Prepare documentation for audits, final reconciliations, and archiving in accordance with GCP guidelines.

• Coordinate the ordering, dispatching, and tracking of study materials.

• Organize data collection forms and other study materials, including logging, tracking, and quality control.

• Assist in tracking and distributing correspondence and reports.

• Manage document translation coordination.

⛳️ Requirements

• Bachelor's degree in a relevant field such as life sciences, healthcare, etc.

• Preferred experience in research or healthcare-related academics or work.

• Exceptional computer skills and proficiency in applications, including Microsoft Word, Excel, PowerPoint, and Outlook.

• Capability to familiarize oneself with ICH-GCP, FDA, and other pertinent regulations and relevant SOPs.

• Strong organizational abilities and capacity to handle multiple tasks with great attention to detail.

• Ability to collaborate effectively in a team-driven environment.

• Excellent written and verbal communication skills in English.

• May be required to sit or stand for extended periods, exceeding 8 hours a day.

🏝️ Benefits

• Comprehensive health insurance options.

• Opportunities for career development and advancement.

• Flexible work hours to promote work-life balance.

• Engaging work environment with a collaborative team.