Remote Site Activation Specialist for Clinical Trials

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

Job summary

Worldwide Clinical Trials is seeking a Site Activation Specialist for remote US-based work. You will coordinate site regulatory documents, support activation milestones, and collaborate with study teams, sites, and regulatory functions to ensure timely start-up and compliance.

Your role requires a bachelor's degree in a scientific field and at least one year in clinical research, with knowledge of ICH-GCP and EU directives.

Qualifications

• Bachelor's degree in medical/biological/health-related science with 1+ year clinical research experience.
• Experience in site activation or regulatory-focused roles preferred.
• Familiarity with ICH-GCP, EU Clinical Trials Directive and applicable regulations.

Responsibilities

• Coordinate collection, tracking, review, and maintenance of site regulatory documents.
• Work with study teams, sites, and stakeholders to complete start-up activities and activation milestones.
• Review study-specific regulatory documentation, identify gaps or quality issues, and drive corrective actions prior to final approval.
• Support development, adaptation, and review of country- and site-specific informed consent documentation.
• Facilitate site identification and feasibility activities, including confidentiality agreements, feasibility questionnaires, and site qualification efforts.
• Monitor site and country-level submission activities and communicate status updates to internal teams and project stakeholders.
• Contribute to country and site intelligence gathering to support study planning, site selection, and activation strategies.
• Maintain compliance with applicable SOPs, ICH GCP guidelines, regulatory requirements, and study-specific processes while supporting continuous quality delivery.

Job description

Worldwide Clinical Trials is seeking a Site Activation Specialist for remote US-based work. You will coordinate site regulatory documents, support activation milestones, and collaborate with study teams, sites, and regulatory functions to ensure timely start-up and compliance.

Your role requires a bachelor's degree in a scientific field and at least one year in clinical research, with knowledge of ICH-GCP and EU directives.