Senior Clinical Research Associate - FSP - Register Your Interest
Remote · Berlin, State of Berlin, Germany or Germany
Berlin, State of Berlin, Germany or GermanyRemoteFull TimeSenior LevelBachelors DegreeLarge
Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Large
Job Summary
Senior Clinical Research Associate (FSP) for oncology in Germany. Responsible for site management, site monitoring, and close-out of investigator sites to ensure patient safety and quality study execution; interface with study team, vendors, and sites; monitor AEs/SAEs and coordinate with Drug Safety; ensure audits and CAPA development where applicable; requires strong knowledge of GCP/ICH and regulatory requirements and at least 3.5 years of site monitoring experience.
Required Qualifications
- Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
- Monitoring Experience: Minimum 3.5 years relevant experience in clinical research site monitoring (preferably in Oncology)
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