Key Responsibilities:

• Perform site selection, initiation, routine monitoring, and close-out visits in accordance with study protocols, GCP, and SOPs.
• Ensure clinical investigations are conducted in compliance with ISO 14155, EU MDR, applicable regulations, and study requirements.
• Build and maintain strong working relationships with investigators, site personnel, and cross-functional study teams.
• Monitor patient safety, data quality, protocol compliance, and timely resolution of study issues and deviations.
• Support investigative product accountability, site documentation management, and essential study records.
• Identify, communicate, and proactively manage study risks, enrollment challenges, and operational issues throughout the trial lifecycle.
• Contribute to regulatory and ethics committee submissions, study documentation reviews, and clinical reporting activities.
• Mentor junior CRAs where required and support continuous improvement initiatives within Clinical Operations.

Requirements:

• Bachelor’s degree in a Life Sciences, Nursing, Biomedical, or related scientific discipline.
• Minimum 5 years of CRA experience, including hands-on monitoring of medical device or clinical research studies.
• Strong knowledge of ICH-GCP, ISO 14155, and European clinical research regulations; familiarity with EU MDR is highly desirable.
• Demonstrated experience conducting independent monitoring visits and managing investigator sites throughout the study lifecycle.
• Experience working with EDC systems, eTMF platforms, and standard clinical trial documentation.
• Excellent communication, stakeholder management, and organisational skills with the ability to work autonomously.
• Fluent German and English language skills are required.

Key Responsibilities:

• Perform site selection, initiation, routine monitoring, and close-out visits in accordance with study protocols, GCP, and SOPs.
• Ensure clinical investigations are conducted in compliance with ISO 14155, EU MDR, applicable regulations, and study requirements.
• Build and maintain strong working relationships with investigators, site personnel, and cross-functional study teams.
• Monitor patient safety, data quality, protocol compliance, and timely resolution of study issues and deviations.
• Support investigative product accountability, site documentation management, and essential study records.
• Identify, communicate, and proactively manage study risks, enrollment challenges, and operational issues throughout the trial lifecycle.
• Contribute to regulatory and ethics committee submissions, study documentation reviews, and clinical reporting activities.
• Mentor junior CRAs where required and support continuous improvement initiatives within Clinical Operations.

Requirements:

• Bachelor’s degree in a Life Sciences, Nursing, Biomedical, or related scientific discipline.
• Minimum 5 years of CRA experience, including hands-on monitoring of medical device or clinical research studies.
• Strong knowledge of ICH-GCP, ISO 14155, and European clinical research regulations; familiarity with EU MDR is highly desirable.
• Demonstrated experience conducting independent monitoring visits and managing investigator sites throughout the study lifecycle.
• Experience working with EDC systems, eTMF platforms, and standard clinical trial documentation.
• Excellent communication, stakeholder management, and organisational skills with the ability to work autonomously.
• Fluent German and English language skills are required.