Remote Site Activation Coordinator for Clinical Trials

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

Job summary

Worldwide Clinical Trials in the United States is seeking a Site Activation Specialist to help bring clinical studies to life by supporting site activation and ongoing regulatory activities. You will collaborate with Site Activation Managers, regulatory teams, study sites, and cross-functional stakeholders to keep start-up activities moving efficiently and in compliance.

Your role focuses on ensuring site readiness, regulatory documentation quality, and timely activation milestones, while

Qualifications

• Bachelor's degree in medical, biological, physical, health, pharmacy, or related science with at least one year of clinical research experience.
• Experience in pharmaceutical, biotechnology, or CRO industries.
• Working knowledge of ICH GCP, EU Clinical Trials Directive, and other clinical research regulations.
• Understanding of site activation activities and regulatory documentation requirements.
• Excellent organizational, prioritization, and time management skills.
• Strong written and verbal communication and ability to collaborate with cross-functional teams.
• Proficiency with Microsoft Word, Excel, PowerPoint, and similar tools.
• English proficiency; multilingual capabilities preferred.

Responsibilities

• Coordinate the collection, tracking, review, and maintenance of site regulatory and essential documents to support site activation and ongoing study requirements.
• Partner with study teams, sites, and functional stakeholders to ensure timely completion of 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 the 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.

Skills

Clinical research knowledge

Organization & time management

Communication skills

MS Office proficiency

English proficiency

Education

Bachelor's degree in life sciences

Tools

MS Office

Job description

Worldwide Clinical Trials in the United States is seeking a Site Activation Specialist to help bring clinical studies to life by supporting site activation and ongoing regulatory activities. You will collaborate with Site Activation Managers, regulatory teams, study sites, and cross-functional stakeholders to keep start-up activities moving efficiently and in compliance.

Your role focuses on ensuring site readiness, regulatory documentation quality, and timely activation milestones, while