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Clinical Research Associate (m/w/d)

Business Type: Clinical Research Organisation
Job Type: Clinical Research Associate (CRA)
Job Level: Experienced (non manager)
Position: Full Time
Location: Germany
Reference: MM2012020
Closing Date: 17/02/20
Job Details:
Role: Clinical Research Associate (m/f/d) Location: Hamburg or Home-based About the role: We are looking for an experienced Clinical Research Associate (CRA) to join our client in Hamburg. The CRA''s essential function is to act as a link between sponsor, CRO and trial site as well as the quality control of early phase clinical trials in-house, as well as multicenter trials at the sites in Germany or other German-speaking countries. Focus of tasks:
  • Performing and reporting site monitoring visits, including site selection, initiation, periodic and close out visits for clinical trials phase I-IV
  • Ensuring adherence to international standards (e.g. ICH-GCP), standard operating procedures and clinical trial protocol
  • Organizing investigator meetings together with the study team
  • Maintaining investigator site files
  • Assessing on-going training requirements of all sites staff and take appropriate action
  • Identifying and escalating protocol deviations, discrepancies in data, and non-compliance to clinical trial protocols
  • Working with different types of eCRF, CTMS systems
  • Feasibility of sites
  • Preselection visits, initiation visits, periodic monitoring and close out visits
  • Collection of essential documents, review and maintenance
  • Close cooperation with the different departments in-house at the CRO as well as vendors/freelance CRAs


  • Degree in a scientific or medical discipline or equivalent
  • At least 3-5 years of experience as a Clinical Research Associate are imperative, ideally including multicenter and multinational trials
  • Familiar with ICH-GCP guidelines, regulatory requirements, monitoring procedures and understanding of the clinical trial processes
  • Experienced in medical device clinical trials and the applicable regulatory requirements
  • Well-structured and organized, target-oriented personality, team player
  • Ability to thoroughly solve problems and issues
  • Fluent in German and English (written and spoken)
  • Ability and motivated to travel, including overnight stays
  • Competent with MS Office applications
  • Candidates with experiences in the indication dermatology will be preferred


Marica Mamic, 0049 89 380 35 864

Posted: 20/01/2020 | NPJ Ref: 248868
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