Clinical Trial Operations Coordinator - Start-Up Focus

Advanced Recruiting Partners; Raleigh (NC); On-site; USD 52,000 - 70,000; Full time

Job summary

Advanced Recruiting Partners in Raleigh, NC seeks a Clinical Support Specialist to join the Clinical Operations team. You will provide essential administrative support, maintain study trackers, and ensure documents are audit-ready to drive efficient trials.

Ideal candidates have 1–3 years in clinical trials or operations, with experience in eTMF, ICH-GCP, and CTMS/SharePoint tools, plus strong organizational and communication skills.

Qualifications

• Bachelor's degree in Life Sciences, Healthcare, or related field preferred.
• 1–3 years of experience supporting clinical trials, operations, or coordination.
• Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
• Strong knowledge of ICH-GCP guidelines and trial documentation.

Responsibilities

• Provide day-to-day administrative support to Clinical Operations project teams.
• Develop, maintain, and update clinical study trackers, reports, and dashboards.
• Coordinate internal and external meetings, prepare agendas, capture minutes, and track action items.
• Maintain eTMF with inspection readiness and GCP/ICH SOP compliance.
• Assist with study start-up activities and regulatory file organization.
• Support Start-Up Managers with site activation and milestone tracking.
• Provide CRA support including site visit docs and study file maintenance.
• Monitor timelines and identify overdue tasks or missing documentation.
• Coordinate communication across Clinical Operations, Regulatory Affairs, Data Management, vendors, and sites.
• Assist with vendor docs, purchase orders, invoices, and project-related admin tasks.
• Generate reports and maintain study metrics for leadership.

Skills

Organizational skills

Time management

Multitasking

Communication

Team collaboration

Self-motivation

Education

Bachelor's degree in Life Sciences or related field

Tools

eTMF

CTMS

SharePoint

Smartsheet

Microsoft Office

Job description

Advanced Recruiting Partners in Raleigh, NC seeks a Clinical Support Specialist to join the Clinical Operations team. You will provide essential administrative support, maintain study trackers, and ensure documents are audit-ready to drive efficient trials.

Ideal candidates have 1–3 years in clinical trials or operations, with experience in eTMF, ICH-GCP, and CTMS/SharePoint tools, plus strong organizational and communication skills.