Clinical Research Nurse

Parexel; Berlin; Vor Ort; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

Parexel is looking for a Clinical Research Nurse in Berlin to provide clinical care for study participants. The role involves coordination and support for clinical studies, ensuring safety and documentation compliance according to protocols. Candidates should be fluent in German with good English skills, have relevant educational backgrounds, and possess strong organizational abilities. The position requires flexibility for shifts, including weekends and holidays.

Qualifikationen

• Fluent in German and good English skills required.
• Experience in medical/surgical settings preferred.
• Computer proficiency, especially with Windows Office.

Aufgaben

• Coordinate and support studies while ensuring subject safety.
• Prepare clinical studies and maintain documentation.
• Provide nursing care from admission to discharge.

Kenntnisse

Fluent German

Good English knowledge (written and oral)

Computer skills (Windows Office)

Organizational talent

Ability to work under pressure

Flexibility in working times

Ability to work in shifts

Ability to work on weekends and holidays

Ausbildung

Education as nurse, MTA, doctor´s assistant, paramedic or similar qualification

Jobbeschreibung

The Clinical Research Nurse is responsible for providing clinical nursing care for all study participants in accordance with departmental policies and procedures and established standards of nursing care and practice in Clinical Trial setting.

Key Accountabilities

• Coordinate and provide support and continuity for the allocated studies
• Supporting all study activities, documentation processes and special needs of a clinical study in conjunction with the Senior Clinical Research Coordinator, Clinical Research Coordinator
• Responsibility for subjects safety and medical data documentation according to the case report forms, study protocol and ICH/GCP guidelines
• Organisation and Preparation of clinical studies, as listed below:
  • Verification and maintenance of the file containing the volunteers informed consent forms
  • Organisation of study specific materials and medical devices in the ward
  • Preparing clinical equipment and areas, maintaining a safe environment for the participating volunteers
  • Preparing ward areas for the study specific needs of the actual studies running in the ward
  • Care and support of the volunteers participating in a study from admission to discharge
  • Providing the volunteers with relevant plans, diary, forms for the assigned studies
  • Perform investigations on subjects (physiological measurements including ECG, Blood Pressure, Lung Function, venous puncture) according to the study protocol including documentation
  • Optional preparation and instruction of subjects for different neuro-physiologic measurements
  • Optional performance of EEG registrations and polysomnographic recordings, measurements of evoked potentials
  • Use of psychological and physiologic test procedures
  • Providing study relevant shift to shift information
  • CRF corrections in agreement with quality management and quality assurance
  • Management of CRF, Source Data storing and archiving after study finalization
  • Issuing of Audit Reports on internal and external quality audit findings
  • Volunteer payment management
  • Resolution of data clarification queries
• Cooperation with the study monitor, incl. preparation of monitor visits, cleaning and correcting of study relevant documents according to monitor/protocol demands
• Participation in study team sessions
• Participation in study initiation sessions
• Participation in sessions with the Sponsor
• Other tasks in the opinion of the manager and need of the CPRU

Skills

• Fluent German and good English knowledge (written and oral)
• Computer skills (Windows Office)
• Organizational talent
• Ability to work under pressure and flexibility in working times
• Ability to work in shifts (early, late, night)
• Ability to work on weekends and holidays

Knowledge And Experience

• Relevant experience in hospitals or medical surgery

Education

• Terminated education as nurse, MTA, doctor´s assistant, paramedic or similar/equivalent qualification/education