Site Activation Specialist - US

Make an Impact as a Site Activation Specialist at Worldwide

Play a key role in bringing clinical research studies to life by supporting site activation and maintenance activities that help ensure studies start on time and remain compliant throughout delivery. In this role, you'll partner closely with Site Activation Managers, regulatory teams, study sites, and cross-functional stakeholders to keep critical start-up activities moving forward efficiently and accurately.

Your work will directly contribute to the quality and completeness of essential regulatory documentation, site readiness, and study activation milestones. From supporting site feasibility and qualification activities to coordinating essential document collection and review, you'll help create a strong foundation for successful clinical trial execution.

Working within a collaborative global environment, you'll build relationships with investigators, site personnel, and internal teams while helping deliver high-quality outcomes that support clinical research and patient-focused innovation.

Where You'll Work

This is a REMOTE role open to candidates based in Remote. You will collaborate with global teams across multiple time zones.

What You'll Do

• 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.

What You'll Bring

• Bachelor's degree in medical, biological, physical, health, pharmacy, or another related scientific discipline, with at least one year of clinical research experience, preferably in site activation or a regulatory-focused role.
• Previous experience within the pharmaceutical, biotechnology, or CRO industry.
• Working knowledge of ICH GCP, 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.
• Excellent organizational, prioritization, and time management skills with the ability to manage multiple activities in a fast-paced environment.
• Strong written and verbal communication skills and the 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 required; multilingual language capabilities and fluency in the local language preferred.