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Clinical Research Associate / Klinischer Monitor (m/w/d)

Berlin
Full-time
Permanent employee

About us

Clinische Studien Gesellschaft (CSG) is a renowned full-service contract research organisation based in Berlin. Our focus is conducting clinical and observational studies for drugs, medical devicesand digital health applications in all indication areas across Europe. As the CRO of the IGES Group, we  tap into a broad spectrum of real-world data. On behalf of our clients, we also conduct research the topics of utilisation, medical need, patient preferences and clinical pathways.

To strengthen our team in the field of clinical research, we are looking for the next possible date for a Clinical Research Associate (CRA)/Senior CRA/Clinical Monitor (m/f/d).

Your mission

  • Planning, preparation and execution of monitoring visits according to SOPs (both onsite and remote)
  • Timely preparation of reports and follow-up documentation of monitoring visits
  • Preparation and submission of application documents for study projects to authorities and ethics committees
  • Management and/or support of study centres
  • Ensuring the validity of the study data and creating data queries
  • Participation in investigator meetings and planning and implementation of studyspecific training sessions

Your profile

  • University degree in the medical-technical/medical-documentary or scientific field or comparable training
  • First professional experience or several years of professional experience as Senior CRA (m/f/d) in a similar field, e.g. as Clinical Monitor in a CRO or a pharmaceutical company
  • Profound knowledge of the relevant regulations (ICH-GCP and AMG, MPG)
  • Ability to solve problems, precise working methods and good analytical skills
  • Strong communication and social skills
  • Very good organisational skills and flexibility
  • Willingness to travel regularly
  • Good written and spoken German and English skills

Our offer

  • Varied and exciting projects
  • Permanent employment and flat hierarchies
  • A pleasant working environment in the centre of Berlin
  • 30 days holiday plus Christmas Eve and New Year's Eve off
  • Flexible working hours and the option of mobile working from home (hybrid)

contact information

If this role appeals to you, we look forward to receiving your detailed application documents (cover letter, CV
and references) stating your salary expectations and earliest possible starting date via the application form or at
personal@csg-germany.com . For further information, please contact Ms Alina Weber (030/230 809 418).