Associate Clinical Research Monitor, m/f/d

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

📋 Description

• Oversees the advancement of clinical studies at investigative sites or within the company's headquarters, ensuring they are executed, documented, and reported in alignment with the study protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and all relevant regulatory standards.

• Develops and nurtures cooperative relationships with investigators, Contract Research Organizations (CROs), affiliated hospitals, and research institutions to initiate and progress clinical studies for investigational products or medical devices.

• Responsible for reviewing adverse events in collaboration with investigators, planning and monitoring timelines, budgets, and milestones, preparing study-related documentation, and generating status reports.

• May assist in the design, development, and management of clinical evaluation projects as applicable.

• Provides training to investigators and site staff.

• Performs duties typical of Clinical Research Associates (CRA), both from a home office and in the field.

• Implements and aids in the preparation of the clinical development strategy outlined by the clinical teams.

• May reach out to qualified investigators and recommend them for study execution and trial commencement.

• Guarantees the recruitment and retention of study participants.

⛳️ Requirements

• Bachelor’s, Master’s, or diploma degree in natural sciences, nursing, or another health-related discipline.

• Demonstrated experience in clinical research monitoring.

• Strong understanding of pertinent regulatory requirements and standards (e.g., GCP, ICH guidelines, FDA CFR, ISO standards, clinical research ethics, EU directives, etc.).

• Excellent verbal and written communication abilities.

• Strong interpersonal skills with a preference for collaborative work.

• Proactive attitude and capability to thrive in a fast-paced, dynamic environment.

• Ability to operate within a matrix organization.

• Solid skills in cross-functional collaboration, decision-making, execution, results orientation, process enhancement, and customer satisfaction.

• Capacity to maintain composure in challenging circumstances and adapt to shifting priorities and competing demands.

• High level of conscientiousness and attention to detail.

• Strong problem-solving abilities.

• Proficient in Word, PowerPoint, Excel, and database applications.

• Business-level fluency in both German and English.

🏝️ Benefits

• Competitive salary.

• Flexible benefits package.