Trial Master File Jobs in Raleigh, NC (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.

****Thank you for your interest in this opportunity! Due to the high volume of applications we receive, we are unable to respond to every applicant individually. If you do not hear from us regarding this role, it means we have moved forward with other candidates at this time. We sincerely appreciate your interest and encourage you to apply for future opportunities that match your experience and career goals.