Remote Site Activation & Regulatory Specialist

Worldwide Clinical Trials; Madrid; À distance; EUR 40 000 - 60 000; Plein temps

Résumé du poste

Worldwide Clinical Trials is seeking a Site Activation Specialist to help sites move through activation and stay compliant during study activities. You will focus on high-quality document delivery and timely activation across Spain.

You will work with Site Activation Managers, Regulatory Affairs and Site Contracts, coordinating start-up, feasibility and maintenance tasks while building strong relationships with investigators and site personnel.

Qualifications

• Minimum four-year college curriculum in medical/biological/physical/health/pharmacy or related science.
• At least one year of clinical research experience, preferably site activation or regulatory support.
• Solid knowledge of ICH GCP, EU Clinical Trials Directive and related guidance.
• Fluency in Spanish and proficiency in English.

Responsabilités

• Coordinate collection, tracking, first review and follow-up of site regulatory documents for timely activation.
• Maintain regular communication with investigative sites and internal teams; resolve issues and escalate risks.
• Support site identification, feasibility activities and start-up with regulatory submissions guidance.
• Contribute to development and review of country/site informed consent forms and translations.
• Collaborate with contracts and budgeting teams to align activation activities with timelines.

Connaissances

Organizational skills

Communication skills

Spanish language

English proficiency

Formation

Bachelor's degree or related science

Outils

Microsoft Office

Description du poste

Worldwide Clinical Trials is seeking a Site Activation Specialist to help sites move through activation and stay compliant during study activities. You will focus on high-quality document delivery and timely activation across Spain.

You will work with Site Activation Managers, Regulatory Affairs and Site Contracts, coordinating start-up, feasibility and maintenance tasks while building strong relationships with investigators and site personnel.