Remote Site Activation & Regulatory Coordinator

Worldwide Clinical Trials; Durham (NC); Remote; USD 60,000 - 119,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Site Activation Specialist to support activation and maintenance activities, ensuring studies start on time and stay compliant. You will collaborate with Site Activation Managers, regulatory teams, sites, and cross-functional partners to keep essential start-up tasks moving smoothly.

The role emphasizes regulatory documentation, site readiness, and timely activation milestones, with a focus on collaboration across global teams and investigators.

Qualifications

• Bachelor’s degree in a scientific discipline with 1+ year of clinical research experience.
• Experience in site activation or regulatory-focused roles preferred.
• Working knowledge of ICH GCP and regulatory guidelines.

Responsibilities

• Coordinate collection, tracking, review, and maintenance of site regulatory docs; support activation.
• Partner with study teams, sites, and stakeholders to complete start-up activities and milestones.
• Review regulatory docs, identify gaps, and drive corrective actions before approval.
• Support development and review of country- and site-specific informed consent documents.
• Facilitate site identification, feasibility activities, confidentiality agreements, and site qualification efforts.
• Monitor submission activities and communicate status to internal teams and stakeholders.
• Contribute to country/site intelligence gathering to support planning and activation strategies.
• Maintain SOPs, ICH GCP guidelines, regulatory requirements, and study-specific processes.

Skills

Organizational skills

Time management

Communication

Cross-functional collaboration

Microsoft Office

Education

Bachelor's degree in medical/biological/physical/health/pharmacy or related scientific discipline

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Worldwide Clinical Trials is seeking a Site Activation Specialist to support activation and maintenance activities, ensuring studies start on time and stay compliant. You will collaborate with Site Activation Managers, regulatory teams, sites, and cross-functional partners to keep essential start-up tasks moving smoothly.

The role emphasizes regulatory documentation, site readiness, and timely activation milestones, with a focus on collaboration across global teams and investigators.