Beschreibung

In this role, you will engage in a variety of tasks, including site selection, monitoring, and closing visits, while ensuring compliance with regulatory standards. You will also have the opportunity to mentor others and specialize in therapeutic areas, making a meaningful impact in clinical research.

Anforderungen

• •University degree in life science, scientific discipline, or apprenticeship in health care
• •Minimum of 12 months of on-site monitoring 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 visits
• •Initiate site visits
• •Monitor site activities
• •Conduct close-out visits
• •Support 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
• •Oversee case report form completion
• •Resolve data queries
• •Collaborate with study site experts and client representatives
• •Engage in remote monitoring as needed
• •Participate in 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