Upsilon Global

Clinical Research Associate / Clinical Project Coordinator- Berlin

Location
Berlin (DE)
Salary
€40- €60,000 per year
Posted
25 Jan 2021
Closes
24 Feb 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

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

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