Clinical Research Associate II

Apsida
Location: Germany
Salary: Competitive

Overview

Our client are an extremely well-established, full-service clinical contract research organization (CRO), which means they offer sponsors support for all aspects of the trial. They provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our client specialise in specific indications of therapeutic expertise across all major areas including oncology, infectious disease, regenerative medicine/gene therapy, immunology and paediatric. They help sponsors set up the trial for success from the very beginning, manage the day-to-day aspects of recruiting for and monitoring a trial as it is in process, help them with dealing with regulatory agencies around the world, write articles about the trial for publication, and so much more.

Job Summary

As a CRA you will be responsible for the successful conduct of clinical trials and serve as main contact for the investigative site by representing them in a professional manner. With their clinical activities growing rapidly, seeing a consistent 15% growth rate over the last decade, they are currently seeking a home-based Clinical Research Associate II to join their Clinical Team in Germany.  If you want an exciting career with a company where you can develop and grow your career even further, work in a supportive environment and continue to contribute to the multiple drug and device approvals they are responsible for, then this is the opportunity for you.

Your Responsibilities

  • Conduct evaluation, initiation, monitoring and close out visits
  • Assist with regulatory and study start-up activities including contract and budget negotiations
  • Ensure clinical data integrity and meet study timelines
  • Provide ongoing updates and support to project management
  • Attend global project meetings including investigator meetings and global team teleconferences
  • Complete assigned training programs in drug development processes, therapeutic areas, Good Clinical Practices (GCPs) and any applicable local regulatory requirements.

Qualifications

  • 1 – 2 years of clinical research experience as a CRA or related profession
  • Life science background
  • Excellent knowledge in ICH-GCP and regulatory requirement
  • Fluent in English and German

The Consultant

Emily Langley

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