Clinical Research Coordinator - Berlin, Deutschland - Parexel

Parexel

Geprüftes Unternehmen

Berlin, Deutschland

vor 1 Woche

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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