The Clinical Research Nurse is responsible for providing clinical nursing care for all study participants an 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:

• Good English knowledge

• 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

• Ability to work under pressure and flexibility in working times

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