CRA II / Sr CRA - FSP Vaccines(m/w/x)

Beschreibung

You will drive clinical excellence by managing site compliance and data integrity across vaccine trials. Your role balances rigorous monitoring with building strong site relationships to advance innovation.

Anforderungen

• •Degree in life sciences, Nursing certification, or equivalent
• •Experience comparable to 1 year clinical monitoring
• •Valid driver's license
• •Equivalent combination of education and experience
• •Experience in Oncology and Vaccine studies
• •Proven clinical monitoring skills
• •Medical terminology and therapeutic area knowledge
• •Knowledge of ICH GCPs and regulations
• •Critical thinking and problem solving skills
• •Ability to manage Risk Based Monitoring
• •Good oral and written communication skills
• •Customer focus and listening skills
• •Organizational and time management skills
• •Effective interpersonal skills
• •Attention to detail
• •Flexibility and adaptability
• •Ability to work independently or in teams
• •Good computer skills and Microsoft Office
• •Fluency in English and German
• •Good presentation skills
• •Willingness for frequent travel and driving

Aufgaben

• •Conduct remote and on-site monitoring visits
• •Assess protocol and regulatory compliance
• •Manage clinical monitoring and site management
• •Follow sponsor-specific procedures and guidelines
• •Ensure adherence to ICH-GCP and SOPs
• •Guarantee subject well-being and data reliability
• •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
• •Perform physical inventory of investigational products
• •Document observations in reports and letters
• •Escalate and resolve observed deficiencies
• •Maintain regular contact with investigative sites
• •Execute tasks per the approved monitoring plan
• •Participate in the investigator payment process
• •Collaborate with team members on finding resolutions
• •Attend and participate in investigator meetings
• •Identify and qualify potential investigative sites
• •Initiate clinical trial sites per regulations
• •Perform trial close-out and material retrieval
• •Ensure essential documents are complete
• •Conduct on-site file reviews
• •Provide trial status updates to management
• •Update clinical trial management systems
• •Facilitate communication between sites and clients
• •Respond to regulatory audits and inspections
• •Complete expense reports and timesheets
• •Assist with project publications and tools
• •Contribute to process improvement initiatives

Tools & Technologien