Senior Clinical Research Associate II – Germany

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

📋 Description

• Act as the primary CTI liaison for designated study sites

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

• Fulfill site visit obligations within the timelines set by the monitoring plan, adhering to regulatory, SOP, and ICH-GCP standards

• Support or supervise study start-up, feasibility assessments, pre-study tasks, and site selection

• Gather, evaluate, and monitor essential and regulatory documentation

• Engage in investigator, client, and project team meetings, including delivering presentations when necessary

• Develop and implement strategies for subject enrollment

• Ensure the appropriate storage, distribution, and accountability of investigational products and trial-related materials

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

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

• Utilize systems and reports to monitor subject status, CRF retrieval, source document verification, regulatory documents, and investigational products

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

⛳️ Requirements

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

• Independent monitoring experience within Germany

• Background in life sciences

• Strong understanding of ICH-GCP and regulatory requirements

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

• Participation in all mandatory general and study-specific training sessions

🏝️ Benefits

• Structured mentoring program

• Leadership development courses

• Dedicated training department

• Ongoing education support

• Hybrid work opportunities

• CTI Cares community and charitable engagement opportunities

• Support for work-life balance

• Chance to contribute to the development of life-changing treatments