Site Activation Specialist- US

Worldwide Clinical Trials • Durham, NC

1d • $60,000 - $119,000 • Remote

About The Position

The Site Activation Specialist supports clinical study site activation and maintenance activities, helping studies start on time and remain compliant throughout delivery. The role works closely with Site Activation Managers, regulatory teams, study sites, and cross-functional stakeholders to advance start-up activities and activation milestones efficiently and accurately. Responsibilities include supporting site feasibility and qualification, coordinating essential document collection and review, and contributing to regulatory documentation quality, site readiness, and study activation. The position is remote and open to candidates based in the United States, with collaboration across global teams and multiple time zones.

Requirements

• Bachelor's degree in medical, biological, physical, health, pharmacy, or another related scientific discipline.
• At least one year of clinical research experience.
• Previous experience within the pharmaceutical, biotechnology, or CRO industry.
• Working knowledge of ICH GCP, the EU Clinical Trials Directive, and other relevant clinical research regulations and guidance.
• Strong understanding of clinical research processes, site activation activities, and regulatory documentation requirements.
• Strong organizational, prioritization, and time-management skills, including the ability to manage multiple activities in a fast-paced environment.
• Strong written and verbal communication skills and ability to collaborate effectively with cross-functional teams and study sites.
• Proficiency with Microsoft Word, Excel, PowerPoint, and other contemporary digital systems.
• Proficiency in English.

Nice To Haves

• Clinical research experience in site activation or a regulatory-focused role.
• Multilingual language capabilities and fluency in the local language.

Responsibilities

• Coordinate collection, tracking, review, and maintenance of site regulatory and essential documents for site activation and ongoing study requirements.
• Partner with study teams, sites, and functional stakeholders to complete start-up activities and activation milestones on time.
• Review study-specific regulatory documentation, identify gaps or quality issues, and drive corrective actions before 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.
• Gather country and site intelligence 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level