Beschreibung

You will drive the success of clinical trials by managing site compliance and data integrity. Your day-to-day involves balancing rigorous monitoring with building strong site relationships.

Anforderungen

• •At least 2 years CRA experience
• •Willingness to travel up to 50-75%
• •Degree in life sciences or equivalent
• •Experience comparable to clinical research monitor
• •Valid driver's license
• •Full right to work in Germany
• •Fluency in English and German
• •Effective clinical monitoring skills
• •Knowledge of medical terminology
• •Application of ICH GCPs and regulations
• •Well-developed critical thinking skills
• •Ability to handle Risk Based Monitoring
• •Effective oral and written communication skills
• •Customer focus and listening skills
• •Effective social skills
• •Strong attention to detail
• •Organizational and time management skills
• •Flexibility and adaptability
• •Ability to work independently or in teams
• •Proficient knowledge of Microsoft Office
• •Good presentation skills
• •Same aptitude for severely disabled applicants

Aufgaben

• •Coordinate all clinical monitoring and site management
• •Conduct remote and on-site compliance visits
• •Manage required trial documentation
• •Ensure adherence to ICH-GCP and SOPs
• •Maintain audit readiness at all times
• •Develop collaborative relationships with investigational sites
• •Apply risk-based monitoring and root cause analysis
• •Identify site process failures and corrective actions
• •Verify data accuracy through SDR and SDV
• •Review case report forms and records
• •Assess investigational products through physical inventory
• •Document observations in reports and letters
• •Escalate and resolve observed deficiencies expeditiously
• •Maintain regular contact with investigative sites
• •Participate in the investigator payment process
• •Provide trial status updates to management
• •Update and maintain clinical trial management systems
• •Perform quality control checks on system reports
• •Identify and initiate qualified investigative sites
• •Manage trial close-out and material retrieval
• •Assist in preparing project publications and tools
• •Facilitate communication between sites and clients
• •Respond to regulatory audits and inspections
• •Complete administrative expense reports and timesheets

Tools & Technologien

Benefits