Clinical Research Associate

Deliver high‑quality clinical data while safeguarding patient safety in global clinical trials.

R&D Partners is seeking a Clinical Research Associate (CRA) to support the Global Clinical Operations (GCO) Center of Excellence. This role focuses on conducting clinical trial activities in alignment with GCO’s mission to deliver high-quality data collection, study acceleration, and technology-enabled innovation. The CRA will ensure compliance with regulatory requirements, maintain patient safety, and uphold product quality standards.

The ideal candidate will demonstrate collaboration, accountability, adaptability, integrity, and a commitment to excellence in clinical research.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Source Verification: Compare Case Report Forms (CRFs) with source documents, verify Informed Consent Forms, and review regulatory and device accountability records.
• Communication: Provide clear written communication to clinical sites and project teams through monitoring reports, follow-up letters, and study memos. Escalate serious issues as needed.
• Training: Ensure site personnel are trained and prepared to conduct studies per protocol and regulations. Maintain training records and site personnel lists.
• Compliance: Ensure adherence to regulatory requirements (ICH-GCP, MDR, GDPR) and internal SOPs. Address and escalate non-compliance issues as required.
• Event Reporting: Identify, document, and report all events per protocol and applicable regulations.
• Collaboration: Participate in study-specific meetings, teleconferences, and training. Work closely with cross-functional teams and study sites.
• Documentation: Manage study requests and collect relevant regulatory and investigator-site documentation.
• Study Maintenance: Update and maintain study-specific monitoring milestones in Clinical Trial Management Systems (CTMS).

Key Skills and Requirements:

Required Qualifications:

• Bachelor’s Degree or equivalent combination of education and experience.
• Fluency in Spanish and English (written and spoken).
• Minimum 5 years of Clinical Field Monitoring experience.
• Strong organizational, communication, and presentation skills.
• Ability to multi-task and work in a fast-paced environment.
• Comfortable traveling up to 80% of the time (mainly in Spain, with occasional short trips abroad).
• Valid driver’s license and access to a personal car for travel.

Preferred Qualifications:

• Experience with Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) systems.
• Medical device experience in Oncology, Rhythm Management, or Endoscopy.
• Proficiency in a third language (e.g., intermediate-level Italian).

For more information, please contact Athi Singata.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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