Clinical Research Associate, CRA
AstraZeneca
full-time
Posted on:
Location Type: Office
Location: Berlin • 🇩🇪 Germany
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- Monitor clinical trials across various oncology studies and ensure correct, complete and timely submission of study data and documents
- Prepare high-quality monitoring visit reports and follow-up letters in a timely manner
- Confident use of relevant study systems, e.g., WBDC, IVRS, etc., and maintenance of the CTMS
- Participate in international study team meetings and investigator meetings
- Contribute to site selection and assessment of recruitment potential
- Initiate study sites, provide training, support and guidance to site staff
- Continuously monitor recruitment performance, site performance and data quality
- Escalate deficiencies to study management
- Maintain proactive communication with the study site and the local study team
Requirements
- Degree in natural sciences or medicine
- Previous experience as a Monitor in the conduct of clinical trials in the field of cell therapy
- Interest in modern monitoring approaches such as Risk-Based Quality Management and Remote Monitoring
- Excellent knowledge of ICH-GCP for the proper conduct of clinical trials
- Knowledge of the relevant laws (AMG) and regulatory requirements
- Strong understanding of medical/clinical issues
- Understanding of different study and process requirements
- Experience monitoring electronic Case Report Forms (Web-Based Data Capture)
- Independent, effective and structured organization
- Analytical and solution-oriented thinking
- Strong team skills and the ability to respond quickly to changing requirements
- Excellent communication skills and very good German and English language skills
- Willingness to travel frequently with overnight stays
Benefits
- Individual development opportunities and a focus on lifelong learning
- A high level of trust, appreciation and room for initiative within a focused and passionate team
- A diverse, inclusive and non-discriminatory working environment
- A sustainable company committed to becoming carbon-negative across the entire value chain by 2030
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trialsmonitoring visit reportsdata quality monitoringelectronic Case Report FormsRisk-Based Quality ManagementRemote MonitoringICH-GCPAMG regulationscell therapy
Soft skills
analytical thinkingsolution-oriented thinkingteam skillseffective organizationcommunication skillsadaptability