Multi-sponsor CRA Germany

Overview

Conduct clinical monitoring activities for multi-sponsor studies across Germany and the DACH region. Ensure site compliance, subject safety, clinical data integrity, and delivery against project requirements.

What you'll do

• Perform site qualification, initiation, monitoring, management, and close-out visits remotely or on site.
• Assess site performance, compliance, risks, and protocol deviations.
• Review source documents, medical records, case report forms, and electronic data capture requirements.
• Resolve data queries and track observations and action items to closure.
• Review investigational product handling, reconciliation, storage, dispensing, and administration.
• Maintain Investigator Site Files and reconcile them with Trial Master Files.
• Support recruitment, audit readiness, investigator meetings, training, and project communications.

What you'll need

• At least 2 years of monitoring experience.
• Bachelor’s degree or RN in a related field, or equivalent education, training, and experience.
• Knowledge of Good Clinical Practice, ICH Guidelines, and applicable regulations.
• Good computer skills and ability to adopt new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Fluency in German and English.
• Ability to travel regularly up to 75%.

Details

• Remote role in Germany.
• Monitoring across the DACH region may be required.
• Preferably based in north-east, west, or central-east Germany.