Clinical Research Associate / Clinical Project Coordinator- Berlin

The CRA/CPC will perform monitoring and site management activities as well as support clinical project management and in-house activities for clinical trials, clinical investigations and other interventional or non-interventional studies or other projects.

Primary Responsibilities:

• • Clinical monitoring and site management for national and international clinical studies of phases I-IV
  • Regulatory activities with authorities, ethics committees and investigators
  • Project management support and in-house activities for clinical research projects
  • Sponsor communication and contact
  • Document management (creation, review, collection, filing, forwarding) including submission documents and Trial Master Files, from Pre-study Phase to Study Closure
  • Support the country responsible Clinical Project Managers or Program Director and their designates and deputies in their oversight tasks, such as updating and/or reviewing project information system(s), investigator fees, status updates and similar, as applicable
  • Prepare checklists, controlling completion status and timelines, updating relevant tracking sheets, remote monitoring activities

JOB REQUIREMENTS

• BA/BS degree in biomedical-related field, life sciences or equivalent field
• Two years experience in on-site monitoring preferred
• Excellent oral and written communication skills in English and German; knowledge of other languages advantageous
• High level of organization, multi-tasking, judgement, and keeping to timelines
• Profound knowledge of ICH-GCP and other relevant regulatory requirements
• Flexible and willing to travel up to 70%
• Anticipate & prevent problems. Able to create backup plans