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Clinical Research Associate CRA (Spain) @ Antal

Clinical Research Associate CRA (Spain) @ Antal

AntalMadrid, Comunidad de Madrid, España
Hace 2 días
Descripción del trabajo

Overview

Clinical Research Associate (CRA)

Location : Spain (Remote)

Job Description

We are seeking a highly motivated Clinical Research Associate (CRA) to support multiple clinical studies. The Contractor will perform monitoring and site management activities while ensuring patient safety, regulatory compliance, and high-quality data in accordance with applicable SOPs, study protocols, and ISO 14155 : 2020.

Contract Details

  • B2B cooperation
  • Services performed according to Client SOPs and study-specific Monitoring Plans.

Qualifications / Requirements

  • Proven experience as a Clinical Research Associate (CRA) or equivalent role.
  • Knowledge of GCP, ISO 14155 : 2020, and regulatory requirements.
  • Strong organizational, communication, and report-writing skills.
  • Ability to work independently and manage multiple studies / sites.
  • Willingness to travel to clinical sites as required.
  • Fluency in English; additional language skills (e.g., Spanish) advantageous.

    • Responsibilities

  • Conduct monitoring activities including visit preparation, on-site visits, follow-up, site contact, and report writing.
  • Perform remote monitoring and interim site management as required.
  • Support site start-up activities including EC / CA submissions / amendments, contract negotiation, and documentation preparation / collection.
  • Attend study meetings and collaborate with cross-functional teams and study sites throughout all study phases.
  • Ensure monitoring of informed consents and site study files, including documentation for patients experiencing serious adverse events (SAEs).
  • Report non-compliance of investigators with their Clinical Study Agreements (CSAs) to the Client.
  • Finalize monitoring reports within 28 calendar days of each clinical site visit.
  • Support audit preparation and responses.
  • Perform additional services or projects only upon written approval from the Client.

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