Clinical Research Associate | Clinical Monitor | Biologe (m/w/d)
SocraTec R&D Concepts in Drug Research and Development GmbH
Job Summary
This role seeks an experienced Clinical Research Associate (CRA) or Clinical Monitor to oversee and execute clinical trials across phases I-III, focusing primarily within Germany. The core responsibilities include planning, conducting, and following up on all monitoring visits (Site Selection, Initiation, Within-Study, and Close Out). The CRA will be instrumental in developing study-specific monitoring concepts and training plans for investigative sites, ensuring seamless study execution by coordinating communication between sites, sponsors, and project stakeholders. A key aspect of the role involves coordinating and providing technical guidance to a monitoring team (Lead Monitoring) on large multicenter studies, ensuring adherence to CTR, ICH guidelines, and internal SOPs. Candidates must possess a scientific degree or medical/medical-technical background, coupled with at least two years of relevant experience, excellent organizational skills, and fluency in both German and English.
Required Skills
Education
Completed scientific degree or completed training in the medical or medical-technical field
Experience
- Minimum 2 years experience as a Clinical Monitor, Study Coordinator, or Project Manager
- Professional experience in clinical monitoring visit execution (Site Selection, Initiation, Close Out)
- Experience in coordinating communication with investigative sites and sponsors
- Experience in ensuring quality standards across multicenter studies
Languages
Additional
- Willingness to travel (primarily within Germany, dependent on the project)
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