Clinical Research Associate I / II

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

📋 Description

• Assist in managing clinical trial sites in accordance with Fortrea SOPs, ICH‑GCP, study protocols, and sponsor requirements, with necessary supervision.

• Aid in the preparation and execution of site monitoring activities, which include site initiation, routine monitoring, and close‑out visits, ensuring patient safety and compliance with protocols.

• Conduct source data verification (SDV), assist in query resolution, and review eCRFs to ensure data quality and completeness.

• Maintain and update critical trial documentation in eTMF and sponsor systems to support readiness for inspections.

• Help track investigational products (IP) and perform accountability checks in partnership with the study team.

• Work collaboratively with cross‑functional teams and escalate issues as necessary, contributing to site performance, quality, and timelines.

⛳️ Requirements

• A university or college degree in life sciences, nursing, pharmacy, or a related discipline.

• Entry-level to 1 year of experience in clinical research, including internships, trainee positions, or up to 12 months of on-site monitoring experience.

• Basic understanding of ICH‑GCP guidelines and the processes involved in clinical trials.

• Strong attention to detail, eagerness to learn, and capability to follow established procedures and documentation standards.

• Proficiency in both German and English, in written and spoken forms.

• Comfortable using clinical systems and tools, with a willingness to travel as necessary for site visits.

🏝️ Benefits

• Flexible work model.

• Competitive benefits.

• Formal training programs.

• Modern clinical systems.

• Continuous learning opportunities.