Clinical Research Associate monitoring clinical studies in immunology and cardiovascular diseases at AstraZeneca. Ensuring accurate data submission and reporting in a collaborative team environment.
Responsibilities
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
Job title
Clinical Research Associate – Central Germany, Frankfurt Area
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