CRA II - Sponsor Dedicated - Madrid, Spain
Remote · Madrid, Madrid, Spain
Job Summary
CRA II with Sponsor Dedicated role based in Madrid, Spain performing site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely) while ensuring regulatory, ICH-GCP and GPP compliance. Responsible for evaluating site staff performance, communicating issues, conducting source document reviews, confirming accurate CRFs, applying query resolution, and ensuring IP inventory and IP labeling per protocol. Supports recruitment, retention, and awareness strategies; participates in Investigator Meetings; and collaborates with sponsor staff and site personnel to achieve project objectives. Requires knowledge of ICH/GCP, regulatory guidance, data systems, and up-to-date SOPs; travel up to 60% may be required. Real World Late Phase responsibilities may apply; title used locally is Site Management Associate II.
Required Qualifications
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- 2.5 years of CRA experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Ability to manage required travel of up to 60% on a regular basis
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