Hybrid Clinical Research Associate – Central Germany, Frankfurt Area

Posted 14 hours ago

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About the role

  • 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

Job type

Experience level

JuniorMid level

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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