Clinical Research Associate I or II(m/w/x)

Beschreibung

In this role, you will engage in various clinical research activities, from site selection to monitoring and mentoring. You will collaborate with experts and ensure compliance with regulatory standards, all while advancing your career in a supportive environment.

Anforderungen

• •University degree in life science, other scientific discipline, or apprenticeship in health care
• •Minimum of one year 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 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
• •Manage case report form (CRF) completion
• •Resolve data queries
• •Collaborate with study site experts and client representatives
• •Participate in remote monitoring as needed
• •Engage 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