CRA

Overview

Conduct clinical monitoring activities for investigator sites in Germany, ensuring regulatory, ICH-GCP, protocol, data integrity and patient-safety compliance.

What you'll do

• Perform site qualification, initiation, monitoring, management and close-out visits remotely or on site.
• Evaluate site performance and escalate serious issues while developing action plans.
• Review source documents, medical records, case report forms and electronic data capture compliance.
• Manage queries and drive resolution within agreed timelines.
• Review investigational product handling, inventory, storage, dispensing and reconciliation.
• Maintain Investigator Site Files and reconcile them with Trial Master Files.
• Document monitoring activities and support recruitment, retention, audit readiness and project timelines.

What you'll need

• Bachelor's degree or RN in a related field, or equivalent education, training and experience.
• Knowledge of Good Clinical Practice, ICH Guidelines and applicable regulatory requirements.
• Previous monitoring experience in Germany.
• Fluency in German and English.
• Good computer skills and ability to adopt new technologies.
• Strong communication, presentation and interpersonal skills.
• Ability to travel up to 75% regularly.

Nice to have

• Ability to train or mentor junior CRAs.
• Experience leading clinical monitoring or project staff meetings under supervision.

Details

• Location: North-east Germany.
• Visits may be performed on site or remotely.
• Regular travel of up to 75% is required.