CRA I - Real World Late Phase - Germany

As a Clinical Research Associate in Real World Late Phase, you monitor and manage trial sites to ensure regulatory compliance and data integrity. You will perform remote and on-site activities across initiation, monitoring, and close-out, collaborating with cross-functional teams to drive study quality. You’ll work within a fast-paced, agile environment to support investigator sites and sponsor requirements, shaping real‑world evidence studies. This role offers meaningful impact by enhancing patient data quality and trial conduct in Germany.

• Conduct site qualification, initiation, interim monitoring, management, and close-out visits (remote or on-site) ensuring ICH-GCP/GPP and protocol compliance
• Assess site performance and staff, escalate issues, and develop action plans with project guidance
• Maintain knowledge of ICH/GCP and local regulations; uphold SOPs/processes
• Verify informed consent processes and protect subject confidentiality
• Evaluate safety factors and data integrity at investigator sites
• Perform CMP/SMP activities including source document review and data verification
• Identify and resolve data queries; support IP inventory, labeling, and storage validation
• Reconcile ISF and TMF, ensure archiving of essential documents
• Document activities via letters, logs, and reports; support recruitment and retention strategies
• Manage site-level activities with scope, budget, and timelines; adapt to changing priorities
• Assume liaison roles with site personnel or CMA; train and ensure site staff compliance
• Prepare for Investigator Meetings and sponsor meetings; participate in global team meetings
• Contribute to audit readiness and follow-up actions
• For Real World Late Phase, operate as Site Management Associate I
• Provide end-to-end site lifecycle support from identification to close-out
• Collaborate with sponsor affiliates, medical science liaisons, and local staff
• Understand local requirements for real world late phase study designs
• Engage in chart abstraction and data collection
• Assist in cross-functional collaboration and knowledge sharing
• Support data capture and tracking in project systems
• Attend training sessions according to project requirements

• Bachelor’s degree or RN in a related field or equivalent
• Knowledge of GCP/ICH guidelines and regulatory requirements
• Strong computer skills and adaptability to new technologies
• Native German language
• Excellent communication and interpersonal skills
• Ability to travel up to 75%
• Location preference: North or Mid/West Germany

• excellent communication
• interpersonal skills
• presentation skills
• GCP/ICH knowledge
• Source Document Review
• CRF data verification