Site Activation Specialist

Worldwide Clinical Trials Holdings, Inc.; United States; Remote; USD 47.000 - 60.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory knowledge

Clinical research

Document management

Communication skills

Spanish language

MS Office

Ausbildung

Bachelor's degree in life sciences

Tools

Word

Excel

PowerPoint

Jobbeschreibung

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we\'re driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you\'re building your career or bringing years of experience, you\'ll have the opportunity to learn, grow, and help shape the future of clinical research.

Make an Impact as a Site Activation Specialist at Worldwide

As a Site Activation Specialist, you\’ll play an important role in helping clinical trial sites move efficiently through activation and remain compliant throughout ongoing study activities. Your focus will be on the quality, completeness, and timely delivery of site regulatory and essential documents.

Working closely with Site Activation Managers, Regulatory Affairs, Site Contracts, investigative sites, and other study teams, you\’ll support activities from site identification and feasibility through start-up and maintenance. You\’ll help keep teams aligned, identify issues early, and support sites in meeting activation milestones.

This role gives you the opportunity to apply your clinical research and regulatory knowledge while building strong relationships with sites and contributing to high-quality clinical trial delivery.

Where You\'ll Work

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

No travel is required.

What You\'ll Do

• 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.

What You\'ll Bring

• 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.

Discover the Difference

We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.