Clinical Trial Assistant (CTA)

Role Summary

We are seeking a Clinical Trial Assistant (CTA) to join our Clinical Operations team. The CTA provides support to ensure the smooth and efficient execution of clinical studies, manages study documentation, tracks trial activities, and coordinates operational tasks in compliance with Good Clinical Practices (GCP), ICH guidelines, and internal procedures. The role collaborates with Clinical Operations, cross-functional teams, vendors, and study sites to maintain accurate records, support study milestones, and help ensure inspection readiness. This position offers hands-on experience in clinical research and contribution to advancing transformative therapies.

Responsibilities

Study Start-Up

• Support the collection, review, and tracking of essential site start-up documents
• Assist with the preparation, distribution, and maintenance of site study materials and binders
• Help track regulatory and ethics committee submissions and approvals

Site Management & Monitoring

• Maintain study trackers for site information, enrollment status, and essential documents
• Assist with scheduling and coordinating site visits, meetings, and teleconferences
• Aid in the distribution and collection of legal documents such as confidentiality agreements, clinical trial agreements, master service agreements, statements of work, etc
• Track and file monitoring visit reports and correspondence to ensure inspection readiness

Vendor Management

• Support coordination with vendors by tracking deliverables, filing documentation, and ensuring study systems are updated
• Assist with site supply logistics, ensuring timely distribution and reconciliation of study materials

Cross-Functional Collaboration

• Collaborate with Clinical Operations, Data Management, Regulatory, and cross functional teams to maintain study documentation and timelines
• Support study team meetings by preparing agendas, distributing materials, and drafting minutes

Documentation & Compliance

• Maintain and update the Trial Master File (TMF) and ensure timely filing of essential documents
• Track and reconcile study documentation, ensuring alignment with GCP, ICH guidelines, and SOPs
• Assist with audit and inspection readiness activities by ensuring documentation is complete, accurate, and accessible

Qualifications

• Bachelor’s degree in life sciences, health sciences, or a related field preferred; equivalent work experience considered
• 1+ year(s) of sponsor experience in Clinical Operations
• Strong organizational skills with keen attention to detail and accuracy
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) and experience with clinical trial systems is a plus
• Excellent communication and interpersonal skills with the ability to work effectively in a team environment
• Ability to manage multiple tasks and prioritize in a fast-paced setting
• Demonstrated ability to problem solve and manage multiple priorities in a fast-paced environment
• Strong organizational, interpersonal, and communication skills
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams) and clinical trial management systems
• Excellent organizational, prioritization and planning skills in a fast-paced team-oriented environment
• Possess a sense of urgency; identify challenges and problems and take the initiative to identify solutions

Additional Requirements

• Ability to travel up to 15%