Senior Clinical Research Associate responsible for site management and monitoring for Karius. Ensures compliance with protocols and GCP guidelines during clinical trials.
About the role
- Clinical Research Associate responsible for monitoring oncological studies at AstraZeneca. Ensuring timely and complete submission of study data and documentation in a complex research environment.
Responsibilities
- Monitoring of clinical trials across various oncology studies and ensuring correct, complete, and timely submission of study data and documents
- Timely preparation of high-quality reports and follow-up letters from monitoring visits
- Confident use of relevant study systems, e.g., WBDC, IVRS, etc., and maintenance of the CTMS
- Participation in international study team meetings and investigator meetings
- Contributing to site selection and assessment of recruitment potential
- Initiation of study sites, training, support and guidance of site personnel
- Ongoing monitoring of recruitment performance, site performance and quality, with escalation of deficiencies to study management
- Proactive communication with study sites and the local study team
Requirements
- University degree in a scientific or medical field
- Prior experience as a monitor in conducting clinical trials in the field of cell therapy
- Interest in modern monitoring approaches such as Risk-Based Quality Management and Remote Monitoring
- Excellent ICH-GCP knowledge for the proper conduct of clinical trials
- Knowledge of relevant legislation (e.g., German Medicines Act - AMG) and regulatory requirements
- Good understanding of medical/clinical issues
- Understanding of different study and process requirements and ability to set the right priorities accordingly
- Experience monitoring electronic Case Report Forms (Web-Based Data Capture) and preparing monitoring reports
- Independent, effective, and structured working style
- Ability to think analytically and solution-oriented
- 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 with a focus on lifelong learning
- A trusting, appreciative environment and scope to shape your role 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 work environment committed to the Diversity Charter
- A sustainable company committed to becoming net negative in CO2 across the entire value chain by 2030
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