Clinical Research Associate I

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

📋 Description

• Assist in managing clinical trial sites while adhering to ICH-GCP guidelines, study protocols, sponsor requirements, and Fortrea SOPs.

• Engage in site initiation, routine monitoring, and close-out visits under the mentorship of seasoned CRA colleagues.

• Perform source data verification (SDV) and aid in data review activities to ensure the quality of data and the safety of patients.

• Provide support to sites regarding study-related inquiries and assist in resolving issues in collaboration with cross-functional teams.

• Maintain documentation related to clinical trials and ensure the completeness and readiness of the eTMF for inspections.

• Aid sites in achieving their recruitment, quality, and timeline goals.

• Contribute to clinical studies in the therapeutic areas of Oncology, Dermatology, Respiratory, Cardiology, and Diabetes.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related scientific field.

• Prior experience in clinical research as a Study Nurse, Study Coordinator, CTA, Clinical Trial Associate, In-House CRA, or a comparable role.

• Strong understanding of clinical trial processes and ICH-GCP guidelines.

• Excellent organizational skills.

• Keen attention to detail.

• Proactive approach to tasks.

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

• Willingness to travel for onsite monitoring visits throughout Germany.

🏝️ Benefits

• A well-structured and supportive environment with defined development pathways and mentoring opportunities.

• Practical exposure to global clinical trials across various therapeutic areas.

• Access to formal training programs.

• Utilization of modern clinical systems.

• Continuous learning opportunities available.

• Flexible working model.

• Competitive benefits package.

• A culture that prioritizes collaboration, quality, and employee well-being.