Studienassistenz (Study Nurse) (all genders) für die Klinik für Intensivmedizin
Core
Support clinical trials in the ICU by collecting patient data, managing biomaterials, and ensuring compliance with GCP and regulatory standards.
Role type
Clinical trial study nurse (ICU)
Builds
Clinical trial data and documentation for Phase II-IV studies
Domain
Healthcare / Clinical Research / Intensive Care
Required skills
ICU patient care experience, clinical trial Phase II-IV experience, data entry, biomaterial handling, GCP knowledge, MS Office, English (written/oral)
Preferred skills
Certified study nurse (BÄK curriculum 120h), knowledge of CTR/ICH E6(R3)/AMG/MPG/MPDG regulations
Technologies
Electronic Case Report Forms, Study Databases, MS Office
Responsibilities
Collect and document study-relevant findings and vital signs, manage and ship biomaterials and blood samples, maintain Investigator Site File and study logs, prepare documents for ethics committees and authorities, assist with monitor visits and audits, participate in team meetings
Seniority
Mid-level, hands-on IC