Beschreibung

In this role, you will engage in various aspects of clinical research, including site selection, monitoring, and mentoring. You will collaborate with experts and ensure compliance with regulatory standards while gaining valuable experience in diverse therapeutic areas.

Anforderungen

• •University degree in life science, other scientific discipline, or apprenticeship in health care
• •Minimum two to four years of on-site monitoring experience or equivalent combination of education, training, and experience
• •Knowledge of clinical research regulatory requirements, GCP, and ICH guidelines
• •Strong written and verbal communication skills, attention to detail, and ability to work in a fast-paced environment
• •Fluency in German at C1 level and good command of English
• •Flexibility to travel up to 40-60% of working time
• •Driver’s license class B

Aufgaben

• •Perform site selection and initiation visits
• •Conduct monitoring and close-out visits
• •Support the development of subject recruitment plans
• •Evaluate site practices for quality and integrity
• •Ensure compliance with GCP and ICH guidelines
• •Track regulatory submissions and recruitment progress
• •Monitor case report form completion and data queries
• •Collaborate with study site experts and client representatives
• •Engage in remote monitoring and study start-up processes
• •Specialize in therapeutic areas for pharmaceutical products or medical devices
• •Mentor less experienced team members
• •Act as a subject matter expert for specific topics

Benefits