Clinical Research Coordinator

An exciting opportunity for a Clinical Research Co-ordinator to work at our Early Phase Unit in Berlin. You will be accountable for the planning, implementation and completion of clinical studies according to the study protocol and ICH/GCP guidelines

Key Accountabilities

• Technical supervision of Clinical Research Nurse, assigned to the studies
• Control and direct activities and staff during key operational aspects of assigned studies
• Organisation and Preparation of clinical studies, as listed below:
• Review of all other study related documents e.g. CRF, Lab Manual, Reference Manual
• Generation of general working instructions, source data sheets and other relevant forms and documents for the allocated clinical studies
• Generation and maintenance of the general and emergency case files, Staff Log, Window Allowance Agreement, Source Data Verification
• Verification and maintenance of the file containing the volunteers informed consent forms
• Organisation of study specific material and medical devices
• Ensuring all study relevant documentations are going to performed according to study protocol and ICH/GCP guidelines
• Overseeing, maintaining and leading the processes and progresses of all allocated studies in conjunction with study physician, project management and data management
• Issuing of Audit Reports on internal and external quality audit findings
• Management of CRF Shipment, Source Data storing and archiving after study finalisation
• Cooperation with the study monitor
• Perform investigations on subjects (physiological measurements including ECG, Blood Pressure, Lung Function, venous puncture and other) according to the study protocol
• Participation in project team meetings
• Administration of Investigational Products

Skills & Knowledge

• Good English knowledge
• Computer skills (Windows Office)
• Organizational talent
• Ability to work under pressure and flexibility in working times
• Ability to work on weekends and holidays
• Knowledge of ICH-GCP Guidelines and the PAREXEL internal Operating Procedures (SOPs)
• Relevant experience in hospitals or medical surgery

Education

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