Clinical Research Associate

Overview

Clinical Research Associate for a single sponsor partnership in Germany, supporting site qualification, monitoring activities, and compliance with ICH-GCP/protocol requirements.

What you'll do

• Perform site qualification, initiation, interim monitoring, and close-out visits.
• Assess site performance and communicate/escalate serious issues with action plans.
• Maintain knowledge of ICH/GCP guidance, applicable regulations, and company SOPs/processes.
• Verify informed consent completion and confidentiality protection for each subject/patient.
• Review source documents/medical records and verify CRF data accuracy and completeness.
• Support query resolution remotely and on-site through to closure within timelines.
• Support site compliance for electronic data capture and investigator/physician site file (ISF) accuracy.

What you'll need

• Bachelor’s degree or RN in a related field or equivalent education/training/experience.
• Knowledge of GCP/ICH guidelines and other applicable regulatory requirements.
• Previous monitoring experience in Germany, preferably in oncology.
• Good computer skills and ability to embrace new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Fluency in German and English.
• Ability to manage required travel of up to 75% on a regular basis.

Details

• Work in Germany (north-east Germany) with on-site or remote tasks as needed.