Clinical Research Associate

Heads; Sevilla; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading company in clinical research is seeking a Clinical Research Associate (CRA) in Spain. The role involves overseeing clinical trials, ensuring compliance with protocols, and supporting Investigators. Ideal candidates will have a degree in Health Sciences, experience as a CRA, and be fluent in English and Spanish. A competitive remuneration package is offered within a supportive team environment.

Formación

• 6-12 months’ experience as a CRA desirable.
• Fluent in English and Spanish, both oral and written.
• Participation in an ICH GCP training course desirable.

Responsabilidades

• Ensure compliance with quality and regulatory standards for clinical trials.
• Monitor clinical trial conduct at sites, verify data accuracy and informed consent.
• Provide training and support to Investigators on study procedures.

Conocimientos

Communication

Organizational skills

Ability to work independently

Multitasking

Educación

Bachelor’s and/or master’s degree in Health Sciences

Descripción del empleo

Heads, a global CRO, is seeking a Clinical Research Associate (CRA) based in Spain for its growing international hematology / oncology clinical trials program.

This is a full-time position.

Job overview :

The CRA is responsible for ensuring that the conduct of a clinical trial at selected investigational sites complies with the approved protocol and amendments, ICH GCP guidelines, SOPs, and applicable laws and regulations. The CRA acts as the primary communication link between the Sponsor, Investigators, and study personnel to facilitate successful study execution. The key responsibility is to safeguard subjects' rights and ensure that clinical data are accurate, complete, and verifiable from source documents.

Main responsibilities :

• Ensure compliance with the company's Quality and Information Security Management Systems, ICH GCP guidelines, local and international legislation, including data protection laws.
• Report protocol deviations and compliance issues to the Line Manager according to SOPs.
• Conduct pre-study visits to evaluate potential sites' resources and facilities.
• Collaborate with Regulatory Affairs and Clinical Operations for submissions, contracts, and financial documentation.
• Explain study procedures to Investigators and provide training and support.
• Prepare and maintain Clinical Trial Files, ensuring proper documentation throughout the study.
• Supply study medication, verify drug accountability, and oversee shipment, storage, and disposal.
• Monitor clinical trial conduct at sites, including verifying data accuracy, informed consent, and compliance with protocols and regulations.
• Report safety information and ensure proper AE/SAE reporting and drug accountability.
• Document monitoring activities and communicate findings to Investigators and the study team.
• Participate in meetings, audits, and inspections, and support site readiness and compliance.
• Assist in feasibility assessments, site selection, and study enrollment management.
• Support financial processes, including Investigator payments.
• Manage study timelines, patient recruitment, and data quality.
• Participate in SOP development and departmental planning.
• Provide coaching and mentorship to less experienced CRAs.

Job Requirements :

• Bachelor’s and/or master’s degree, preferably in Health Sciences.
• 6-12 months’ experience as a CRA is desirable.
• Fluent in English and Spanish, both oral and written.
• Participation in an ICH GCP training course is desirable.
• Good computer, communication, and organizational skills.
• Ability to work independently and as part of a team.
• Effective communication skills, diplomatic and clear.
• Ability to handle stressful situations, meet deadlines, and multitask.
• Compliance with SOPs, regulations, and ethical standards.
• Willingness to travel frequently, including international trips, evenings, and overnight stays.

Join our multidisciplinary team of scientists and healthcare professionals in a friendly work environment. We offer a competitive remuneration package.

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