Remote Site Activation & Regulatory Coordinator

Worldwide Clinical Trials Holdings, Inc.; United States; Remote; USD 47,000 - 60,000; Full time

Job summary

Worldwide Clinical Trials is hiring a Site Activation Specialist for a remote role open to candidates based in Spain. You will work with global teams to move sites through activation, ensuring regulatory and essential documents are accurate and timely.

You will support feasibility, regulatory submissions, and site communications, coordinating with Site Activation, Regulatory Affairs, and Site Contracts teams while upholding ICH GCP and EU guidelines.

Qualifications

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or another related science.
• At least one year of clinical research experience, preferably within site activation or a regulatory-related function, together with previous pharmaceutical or CRO industry experience.
• Good knowledge of ICH GCP, the EU Clinical Trials Directive, and other relevant clinical research conduct guidance.
• Strong organizational, planning, time management, and prioritization skills, with the ability to manage multiple activities while maintaining quality and timelines.
• Strong written and verbal communication skills and a collaborative, team-oriented approach.
• An understanding of clinical research processes, country-level cultural norms, and local healthcare systems, with the ability to build effective relationships with investigators and key site personnel.
• Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint, with an aptitude for contemporary digital systems considered helpful.
• Fluency in Spanish and proficiency in English.

Responsibilities

• Coordinate the collection, tracking, first review, and follow-up of site regulatory and essential documents to support timely site activation and ongoing maintenance.
• Maintain regular communication with investigative sites and internal teams, resolving document issues and escalating risks to the Site Activation Manager when needed.
• Support site identification and feasibility activities, including Confidential Disclosure Agreements, Site Feasibility Questionnaires, country and site intelligence, and preliminary potential site lists.
• Support country and site-specific start-up activities, including Regulatory Authority and Ethics Committee submissions under the direction of Regulatory Affairs and the Site Activation Manager.
• Contribute to the development, adaptation, and review of country- and site-specific informed consent forms and support translations in line with applicable procedures.
• Coordinate with relevant functional teams to prioritize essential document collection and review, helping to keep site start-up activities synchronized.
• Support site contract and budget activities through liaison with sites under the direction of the Site Contracts team.
• Maintain compliance with applicable SOPs, ICH GCP, EU requirements, and relevant country and local regulatory requirements throughout site activation activities.

Skills

Regulatory knowledge

Clinical research

Document management

Communication skills

Spanish language

MS Office

Education

Bachelor's degree in life sciences

Tools

Word

Excel

PowerPoint

Job description

Worldwide Clinical Trials is hiring a Site Activation Specialist for a remote role open to candidates based in Spain. You will work with global teams to move sites through activation, ensuring regulatory and essential documents are accurate and timely.

You will support feasibility, regulatory submissions, and site communications, coordinating with Site Activation, Regulatory Affairs, and Site Contracts teams while upholding ICH GCP and EU guidelines.