Clinical Research Coordinator

vor 2 Wochen

Berlin, Deutschland Parexel Vollzeit

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
- 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

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