Senior Clinical Research Associate

Senior Clinical Research Associate role at a large contract research organization supporting sponsor-dedicated dermatology and rare disease trials. Responsibilities include study setup, monitoring, regulatory submissions, and site management across phases II-IV in multiple U.S. states.

Responsibilities

• Independently set up, monitor, and close out investigational sites for clinical studies
• Submit protocols and consent documents for ethics and IRB approval
• Prepare regulatory submissions and review study documentation
• Address sponsor-generated queries and manage study cost efficiency
• Potentially train and mentor other clinical research associates

Requirements

• 18+ months clinical research monitoring experience in phase I-III trials
• College degree in medicine, science, or equivalent field
• Experience with medium-sized studies including startup and closeout
• Knowledge of ICH-GCP guidelines and ability to review medical data
• Fluent written and verbal communication in German and English
• Valid driving license and ability to travel 60% domestically and internationally

Compensation: $110,520-$138,150 base