Clinical Monitor, Clinical Research Associate, CRA

This is a fully remote position, open to applicants in Germany.

📋 Description

• Organize, coordinate, and oversee clinical trials in compliance with ICH-GCP guidelines and internal SOPs.

• Recruit, select, and train investigators as well as study sites.

• Conduct study initiation visits, routine monitoring visits (both on-site and remote), and close-out visits at study sites across Germany.

• Communicate effectively with study sites and maintain accurate written documentation.

• Identify and address on-site issues, escalating them to the study sponsor as needed.

• Prepare and submit necessary documentation to ethics committees and relevant authorities.

• Assist with correspondence activities.

• Monitor project schedules and deadlines closely.

• Maintain study data in databases, including Microsoft Access and Microsoft Excel.

• Support regulatory submission processes and uphold the Trial Master File (TMF).

⛳️ Requirements

• A minimum of 1 year of experience as a Clinical Research Associate / Clinical Monitor.

• Strong understanding of ICH-GCP and the German Medicinal Products Act (AMG).

• Proficient in standard PC applications, especially Microsoft Office.

• Good command of written and spoken English.

• Excellent organizational abilities, independence, flexibility, and dependability.

• Strong team spirit, effective communication skills, and an open-minded attitude.

• Familiarity with monitoring oncology studies is a plus.

🏝️ Benefits

• Engaging and diverse role within a growing company.

• Stable employment.