CRA II - multi-sponsor (north-east Germany)

In this role you support clinical trial sites to ensure regulatory and protocol compliance across a multi-sponsor program. You work with cross-functional teams to monitor data integrity, manage site activities, and drive quality through both remote and on-site oversight. You help prepare for audits, contribute to site recruitment and training, and ensure timelines and budgets are met. This position offers the chance to contribute to patient-focused trials within a global, agile team.

• career development and progression
• supportive and engaged line management
• therapeutic area training
• peer recognition
• total rewards program
• inclusive culture

• Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) ensuring GCP, GPP, and protocol compliance
• Evaluate site performance and escalate issues with action plans
• Maintain knowledge of ICH/GCP and applicable regulations and SOPs
• Verify informed consent processes and protect subject confidentiality
• Conduct Source Document Review and CRF data verification; drive query resolution
• Manage IP inventory, reconciliation, and storage/security in line with protocol
• Reconcile ISF and TMF, ensure archiving of essential documents
• Support subject recruitment, retention, and awareness strategies
• Enter data into tracking systems and monitor observations and action items
• Understand project scope, budgets, timelines and manage site-level activities
• Act as liaison with study site personnel and support training/compliance
• Prepare for and attend Investigator Meetings and sponsor meetings
• Assist audit readiness and follow-up actions
• Complete required trainings and maintain regulatory knowledge
• Travel up to 75% as needed
• Monitor across DACH region as required

• Bachelor’s degree or RN in related field or equivalent experience
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• At least two years of monitoring experience
• Strong computer skills and willingness to adopt new technologies
• Excellent communication, presentation, and interpersonal skills
• Fluency in German and English
• Willingness to travel up to 75% and preferably located in north-east Germany
• Experience with remote monitoring and data capture processes

• communication skills
• interpersonal skills
• presentation skills
• ICH-GCP knowledge
• regulatory compliance
• electronic data capture understanding