Clinical Research Associate – Central Germany, Frankfurt Area
AstraZeneca
full-time
Posted on:
Location Type: Hybrid
Location: Hamburg • Germany
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About the role
- Monitoring of clinical studies across various indications (primarily immunology; respiratory, metabolic and cardiovascular diseases)
- Ensuring the correct, complete and timely transmission of study data and documents
- Timely preparation of high-quality monitoring visit reports and follow-up letters
- Confident use of relevant study systems, e.g., WBDC, IVRS, and maintenance of the CTMS
- Participation in international study team meetings and investigator meetings
- Contribution to site selection and assessment of recruitment potential
- Site initiation, training, support and guidance of site staff
- Ongoing monitoring of recruitment performance, site performance and quality
- Escalation of deficiencies to the study management
- Proactive communication with sites and the local study team
Requirements
- Degree in a natural science or medical field
- Several years of experience as a monitor conducting Phase II and III clinical trials, preferably in CVRM (hypertension, CKD and diabetes), and experience conducting studies in eosinophilic esophagitis
- Interest in modern monitoring approaches such as Risk-Based Quality Management and Remote Monitoring
- Excellent ICH-GCP knowledge to ensure proper conduct of clinical trials
- Knowledge of relevant laws (AMG) and regulatory requirements
- Experience with regulatory inspections and/or audits
- Good understanding of medical issues
- Ability to understand different study and process requirements and to set the right priorities accordingly
- Experience monitoring electronic Case Report Forms (Web-Based Data Capture) and preparing monitoring reports
- Independent, effective and structured organisation
- Analytical and solution-oriented thinking skills
- Team player, flexible and able to respond quickly to changing requirements
- Strong 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
- High levels of trust, appreciation and scope for contribution within a focused and passionate team
- Office space in the heart of Hamburg enabling collaborative, flexible and agile working
- A diverse, inclusive and non-discriminatory working environment that actively values differences and welcomes applications from all qualified candidates
- A sustainable company committed to becoming CO2-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 reportsRisk-Based Quality ManagementRemote MonitoringICH-GCPregulatory inspectionselectronic Case Report FormsWeb-Based Data Capturedata transmissionsite performance monitoring
Soft skills
analytical thinkingsolution-oriented thinkingteam playerflexibilitystrong communication skillseffective organizationindependenceproactive communicationability to prioritizeresponsiveness to change