Clinical Research Associate I - Barcelona
On-siteBarcelona, Catalonia, Spain
Job Summary
Conduct routine monitoring, closeout, and initiation visits for clinical sites while maintaining study files and liaising with vendors. Verify informed consent adherence, review source documents for data integrity, and monitor for missing or implausible data. Manage investigator site budgets, track Serious Adverse Event reporting, and prepare accurate trip reports. Perform CRF review and query resolution, assist with training new employees, and coordinate designated projects. Undertake feasibility work, participate in Quality Control Visits, and manage registry and EC submissions. Requires a relevant degree, six months of experience, valid driver's license, and fluency in English and local language.
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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