We are seeking a dedicated Clinical Research Nurse to join our Clinical Pharmacology Research Unit (CPRU).
In this role, you will provide comprehensive clinical nursing care to study participants while ensuring strict adherence to departmental policies, established nursing standards, and ICH/GCP guidelines. You will be instrumental in delivering high-quality clinical research support across multiple concurrent studies.
Key Responsibilities
Study Coordination & Support
- Coordinate and provide continuity of support across allocated studies in collaboration with the Clinical Research Coordinator
- Support all study activities, documentation processes, and special requirements
- Ensure subject safety and accurate medical data documentation in accordance with case report forms (CRFs), study protocols, and ICH/GCP guidelines
Study Preparation & Organization
- Verify and maintain informed consent documentation for all study volunteers
- Organize and maintain study-specific materials and medical devices
- Prepare and maintain clinical equipment and safe study environments
- Configure ward areas to meet study-specific requirements
- Provide comprehensive care and support to volunteers from admission through discharge
Subject Assessments & Investigations
- Perform physiological measurements including ECG, blood pressure, lung function testing, and venipuncture according to study protocol
- Document all investigations accurately and completely
- Prepare and instruct subjects for neuro-physiologic measurements as required
- Perform EEG registrations and polysomnographic recordings where applicable
- Administer psychological and physiologic test procedures
Documentation & Data Management
- Provide volunteers with study-relevant documentation, diaries, and forms
- Manage CRF corrections in coordination with quality management and assurance teams
- Manage CRFs, source data storage, and archiving following study completion
- Resolve data clarification queries promptly
- Issue audit reports on internal and external quality audit findings
Stakeholder Engagement
- Cooperate with study monitors, including preparation for monitor visits and document review
- Participate in study team sessions, study initiation meetings, and sponsor sessions
- Communicate shift-to-shift study-relevant information to the team
- Manage volunteer payments and incentives
Required Qualifications
Education
- Completed nursing qualification (Registered Nurse/Nurse), MTA (Medical Technical Assistant), doctor's assistant, paramedic, or equivalent qualification
Experience
- Relevant experience in a hospital or medical/surgical setting
Skills & Competencies
- Fluent German and good written and oral English proficiency
- Proficient with Windows Office applications
- Strong organizational and time management skills
- Ability to work effectively under pressure
- Flexibility with shift work (early, late, night shifts)
- Availability for weekend and holiday work
- Attention to detail and commitment to data accuracy
- Strong communication and teamwork skills.