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Worldwide Clinical Trials

Contract research organization delivering clinical trials

Site Activation Specialist

Clinical Research OperationsPosted on Nov 9
Full-timeRemote in USA$60k - $119k /yr

About the Job

Requirements

  • A 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, the EU Clinical Trials Directive, and other relevant clinical research regulations and guidance.
  • A strong understanding of clinical research processes, site activation activities, and regulatory documentation requirements.
  • Organizational, prioritization, and time management skills 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.

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.

Desired Qualifications

  • Site activation or regulatory-focused clinical research experience is preferred.
  • Multilingual language capabilities and fluency in the local language are preferred.

About the Company

Worldwide Clinical Trials

Contract research organization delivering clinical trials

Worldwide Clinical Trials is a contract research organization that provides drug development services for pharmaceutical and biotech companies, focusing on running clinical trials to bring new medicines to market. Its core work centers on the science and logistics of clinical trials—designing studies, coordinating sites and investigators, and managing data and regulatory processes to advance drug candidates through development. The company differentiates itself through its specialized, science-driven approach and global expansion achieved via strategic acquisitions, building a larger network and broader capabilities to support complex trial programs. After a history of ownership changes, including a re-launch in 2007 and a majority stake sale in 2023, the firm aims to grow further under new ownership while continuing to offer focused clinical trial services that support medical advancement.

Company size
1,001-5,000
Company stage
Acquired
Total funding
Not listed
Headquarters
Morrisville, NC
Founded
1986

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