Overview
Clinical Research Associate (CRA) for a single-client partnership in Germany, supporting clinical sites in Berlin/Leipzig/Dresden.
What you'll do
- Perform site qualification, initiation, interim monitoring, and close-out visits.
- Ensure regulatory/ICH-GCP/GPP and protocol compliance for monitored sites.
- Evaluate site and staff performance and recommend site-specific actions.
- Verify informed consent documentation and protect subject/patient confidentiality.
- Assess factors affecting safety and clinical data integrity (e.g., protocol deviations, pharmacovigilance issues).
- Conduct source document review and verify CRF data accuracy and completeness.
- Drive query resolution to closure within agreed timelines and maintain site file (ISF/TMF) accuracy.
What you'll need
- Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
- Knowledge of Good Clinical Practice (ICH) guidelines and applicable regulatory requirements.
- Fluency in German and English.
- Good computer skills and ability to adopt new technologies.
- Excellent communication, presentation, and interpersonal skills.
- Ability to manage required travel for monitoring visits.
Details
- Location: Berlin/Leipzig/Dresden area (Germany).
- Work mode: on-site or remotely for monitoring/close-out visits.
Read the full description and apply on the company’s own careers page.
