Remote Clinical Site Activation Specialist

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 of clinical study sites. You will work with Site Activation Managers, regulatory teams, and sites to ensure timely startup activities and compliant study delivery.

The role emphasizes collaboration with investigators and cross-functional teams across time zones in a remote setting, focusing on regulatory documentation and site readiness for successful trial execution.

Qualifications

• Bachelor’s degree in a science field with at least 1 year of clinical research experience.
• Experience in pharmaceutical/biotech/CRO industry.
• Working knowledge of ICH GCP, EU Clinical Trials Directive, and related regulations.
• Strong organizational and time management skills.
• Excellent communication and collaboration across cross-functional teams.

Responsibilities

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

Skills

Clinical research

Regulatory knowledge

ICH GCP

Documentation

Education

Bachelor's degree in life sciences

Tools

Microsoft Word

Excel

PowerPoint

Job description

Worldwide Clinical Trials is seeking a Site Activation Specialist to support activation and maintenance of clinical study sites. You will work with Site Activation Managers, regulatory teams, and sites to ensure timely startup activities and compliant study delivery.

The role emphasizes collaboration with investigators and cross-functional teams across time zones in a remote setting, focusing on regulatory documentation and site readiness for successful trial execution.