Clinical Research Associate CRA (Spain) @ Antal

Antal; Madrid; A distancia; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A clinical research organization is seeking a highly motivated Clinical Research Associate (CRA) to support multiple clinical studies. The role includes monitoring activities, ensuring patient safety, regulatory compliance, and high-quality data management. Ideal candidates will have proven experience as a CRA, strong communication skills, and the ability to work independently. This position offers remote work flexibility.

Formación

• 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.

Responsabilidades

• Conduct monitoring activities including visit preparation, on-site visits, follow-up, and report writing.
• Perform remote monitoring and interim site management as required.
• Support site start-up activities including EC/CA submissions/amendments and contract negotiation.
• Attend study meetings and collaborate with cross-functional teams.
• Ensure monitoring of informed consents and site study files.
• Report non-compliance of investigators.
• Finalize monitoring reports within 28 calendar days after visits.
• Support audit preparation and responses.

Descripción del empleo

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.