Clinical Research Associate

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/amendments, ICH GCP guidelines, SOPs, and applicable laws and regulations. They act as the primary communication link between the Sponsor, Investigators, and study personnel, fostering successful working relationships. The key responsibility is to ensure subjects' rights are protected and that all clinical trial 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, and applicable legislation, including data protection laws.
• Report deviations from the protocol, GCP guidelines, or legislation to the Line Manager according to SOPs.
• Conduct pre-study visits to evaluate investigational sites’ resources and facilities.
• Collaborate with Regulatory Affairs and Clinical Operations for submissions and contracts, including managing hospital IEC submissions and study contract preparations.
• Explain study purposes and procedures to Investigators and provide training on trial conduct.
• Maintain and update clinical trial files, ensuring proper documentation and collection of essential documents.
• Supply study medication to sites, verify drug accountability, and oversee shipment, storage, and destruction as applicable.
• Monitor trial conduct at sites, including verifying Investigator qualifications, data accuracy, and informed consent procedures.
• Review recruitment progress, manage trial supplies, and ensure proper site documentation.
• Report safety information, including adverse events, and ensure timely submissions to regulatory bodies.
• Prepare reports on monitoring activities and participate in study meetings.
• Assist with site audits and inspections, ensuring readiness and compliance.
• Support feasibility assessments, site selection, and study site closure.
• Participate in departmental planning, SOP development, and provide coaching to less experienced CRAs.

Job Requirements :

• Bachelor’s and/or master’s degree, preferably in Health Sciences.
• Previous CRA experience (6-12 months desirable).
• Fluent in English and Spanish, both oral and written.
• Completion of an ICH GCP training course (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, flexible timelines, and workload.
• Capable of managing multiple issues simultaneously.
• Adherence to SOPs, regulations, and ethical principles.
• Willingness to travel frequently, including evenings and overnight stays.

Join our multidisciplinary team of scientists and healthcare professionals in clinical research. We offer a competitive remuneration package.

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