Lead Clinical Research Associate

I am working with a large CRO that is looking for a Lead Clinical Research Associate to expand their team in Germany.

Responsibilities:

• Provide operational expertise and leadership to multiple clinical trial teams
• Ensure the effective and efficient delivery of all aspects of multiple studies through all phases
• Proactively maintain compliance through identification/mitigation of risk and ensuring adherence to ICH, GCP, SOPs, and the study protocol over the life of the study.
• Conduct site audit preparation visits, resolve or support resolution of site audit findings
• Supervise study activities, timelines, and schedules on a country/regional level
• Comply with Good Clinical Practice (GCP), company SOPs and all applicable regulatory requirements
• Provide ongoing updates and support to project management

Requirements:

• At least 4 years’ experience of independent monitoring
• Minimum of 6 months working purely as a Lead CRA
• Fluent in German and English
• Oncology background is preferred
• Excellent knowledge of ICH-GCP and any other relevant, local regulatory requirements

If you’re interested in this role, please get in touch and I will be happy to discuss this in further detail: roxanna.keshavarz@rbwconsulting.com / +44 1273 952187