Clinical Research Associate II – Senior Clinical Research, CRA

This is a fully remote position, open to applicants in Germany.

📋 Description

• Act as the primary contact for assigned study sites at CTI.

• Carry out pre-study, site initiation, interim monitoring, and close-out visits.

• Deliver site visit tasks with high quality and within the timelines specified in the Monitoring Plan.

• Comply with regulatory standards, SOPs, and ICH GCP guidelines.

• Assist with or supervise study start-up, feasibility, pre-study tasks, and site selection processes.

• Gather, review, and maintain essential and regulatory documents.

• Complete mandatory general and study-specific training sessions.

• Engage in meetings with investigators, clients, and project teams, including making presentations.

• Develop and implement strategies for subject enrollment.

• Ensure correct storage, dispensing, and accountability of investigational products and trial materials.

• Execute site management tasks and provide status updates to the Clinical Project Manager.

• Conduct remote monitoring in accordance with the study-specific Monitoring Plan.

• Monitor subject status, retrieve CRFs, review source documents, and manage regulatory documents and investigational products using various systems and reports.

• Contribute to project-specific tasks as a member of the Project Team.

⛳️ Requirements

• 3–5 years of experience in clinical research as a CRA or in a related field within Germany.

• Experience with independent monitoring in Germany.

• Background in life sciences.

• Strong understanding of ICH-GCP and regulatory standards.

• Proficient in spoken and written German and English, at least at Level B2.

🏝️ Benefits

• Structured mentoring program.

• Leadership development courses available.

• Dedicated training department to support your growth.

• Continuous education and professional development assistance.

• Hybrid work arrangements offered.

• CTI Cares initiatives to contribute positively to the community and the world.

• Recognized for an award-winning, people-centric culture.

• Engage in work that advances medicine and contributes to life-changing treatments.