Clinical Research Associate I - Madrid
On-siteMadrid, Madrid, Spain
Job Summary
Conduct routine monitoring and closeout of clinical sites, including pre-study and initiation visits, while maintaining study files and liaising with vendors. Verify informed consent procedures and protocol adherence to protect study patients, review source documents for data integrity, and monitor for missing or implausible data. Manage site budgets, track Serious Adverse Events, and ensure audit readiness by preparing accurate trip reports. Independently perform CRF reviews, generate queries, and assist in recruiting investigators and preparing regulatory submissions. Coordinate designated clinical projects as a Local Project Coordinator and provide training and mentoring to new employees.
Required Qualifications
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
- Basic knowledge of Regulatory Guidelines
- Basic understanding of the clinical trial process
- Fluent in local office language and in English, both written and verbal
- Six (6) months experience in a related role (e.g., site management, in-house CRA, study coordinator, research nurse, etc.)
- Ability to work within a project team
- Good planning, organization, and problem-solving skills
- Good computer skills with good working knowledge of a range of computer packages
- Works efficiently and effectively in a matrix environment
- Valid Driver's License
- Travel, including air travel, may be required and is an essential function of the job
Desired Qualifications
- One (1) or more year's additional experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing)
- 6 months on site monitoring experience
- Demonstrated ability to conduct clinical operations activities most effectively and efficiently
- Attention to detail
- Methodical approach to work
- Understanding of medical and clinical research terminology and clinical research processes
- An understanding of the basics of physiology, pharmacology, and medical devices (when applicable)
- Understanding of the principles of ICH GCP, ISO 14155 (if applicable) and regulatory requirements
- Good computer literacy with working knowledge of PCs, Windows, and Microsoft Office applications
- Good oral and written internal and external communication
- Strong interpersonal team and organizational skills, personal presentation
- Experience using a clinical trial management system (CTMS)
- For medical device positions, experience in providing customer service to device end users
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