Director Trial Master File Jobs (NOW HIRING)

Clinical Support Specialist

Location: Raleigh, NC (Hybrid)

Position Summary

The Clinical Support Specialist provides critical operational and administrative support to the Clinical Operations team. This individual partners closely with Clinical Trial Managers, Start-Up Managers, Clinical Research Associates (CRAs), and cross-functional project teams to ensure clinical studies are organized, compliant, and executed efficiently. The ideal candidate is highly organized, detail-oriented, and thrives in a fast-paced clinical research environment.

Key Responsibilities

• Provide day-to-day administrative support to Clinical Operations project teams.
• Develop, maintain, and update clinical study trackers, reports, and project dashboards.
• Coordinate internal and external meetings, prepare agendas, capture meeting minutes, and track action items.
• Establish, organize, and maintain the electronic Trial Master File (eTMF), ensuring inspection readiness and compliance with Good Clinical Practice (GCP), ICH guidelines, and standard operating procedures (SOPs).
• Assist with study start-up activities, including the collection and organization of essential documents and regulatory files.
• Support Start-Up Managers with site activation activities, document tracking, and milestone management.
• Provide administrative support to Clinical Research Associates (CRAs), including preparing site visit documentation, maintaining study files, and tracking follow-up items.
• Monitor study timelines and proactively identify overdue tasks or missing documentation.
• Coordinate communication between Clinical Operations, Regulatory Affairs, Data Management, vendors, and investigative sites.
• Assist with vendor documentation, purchase orders, invoices, and other project-related administrative activities.
• Generate reports and maintain study metrics for project leadership.
• Ensure all study documentation is complete, accurate, and audit-ready.
• Support continuous process improvement initiatives and the development of Clinical Operations tools, templates, and best practices.
• Perform additional project coordination and administrative duties as assigned.

Qualifications

Required

• Bachelor's degree in Life Sciences, Healthcare, or a related field preferred.
• 1–3 years of experience supporting clinical trials, clinical operations, or project coordination within a pharmaceutical, biotechnology, contract research organization (CRO), or medical device environment.
• Strong understanding of clinical research processes, ICH-GCP guidelines, and clinical trial documentation requirements.
• Experience working with electronic Trial Master File (eTMF) systems.
• Proficiency with Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook.
• Excellent organizational, time management, and multitasking skills.
• Strong written and verbal communication abilities.
• Ability to manage multiple priorities while maintaining exceptional attention to detail.
• Self-motivated with the ability to work both independently and collaboratively in a team environment.

Preferred Qualifications

• Experience as a Clinical Trial Assistant (CTA), Clinical Trial Associate, Clinical Project Coordinator, Clinical Operations Assistant, or similar role.
• Familiarity with study start-up activities and essential regulatory documentation.
• Experience supporting multiple clinical studies, including multicenter or global trials.
• Experience using Clinical Trial Management Systems (CTMS), SharePoint, Smartsheet, or other project management software.

What You'll Bring

• Exceptional organizational skills and meticulous attention to detail.
• A proactive, solution-oriented approach to problem-solving.
• Strong interpersonal skills with the ability to build collaborative relationships across cross-functional teams.
• A commitment to quality, compliance, and operational excellence.
• The ability to thrive in a dynamic, fast-paced clinical research environment.

Career Opportunity

This position offers an excellent opportunity for a professional looking to build a long-term career in Clinical Operations while gaining exposure to all phases of clinical trial execution in a collaborative and growth-oriented environment.