CRA Senior Clinical Monitoring

CRA Senior Clinical Monitoring

Biorasi

Paris, France

As a Clinical Research Associate your role is for example:

  • Organization of all types of site visits including Site Selection, Initiation, Monitoring, and Close-out;
  • Responsibility of the drug accountability and other monitor activities to assure adherence to Good Clinical Practices (ICH GCP), SOPs, and study protocols;
  • Ensuring the availability of selected study centres, adequate qualification resources, suitable volunteers and qualified examiner;
  • Monitoring of clinical trials including the trial-specific monitoring plan and compliance with regulations, ICH/GCP guidelines and IRB approvals;
  • Responsibility for various documents and approvals such as submissions/notifications to national health authorities, submissions to IRB/Ethics Committees, AE/SAE expertise, updates, protocol changes, safety reports;
  • Working with the Regulatory Division for timely results;
  • Contact person for the clinical sites and reporting to the study director.

That is your Candidate Profile

  • Bachelor’s degree, preferably in biomedical sciences or related scientific discipline;
  • Prefer a minimum of 4 years monitoring experience;
  • Thorough Knowledge of FDA regulations and ICH/GCP guidelines;
  • Ability to travel up to 80% depending on project;
  • Very good skills in MS-Office;
  • Fluent knowledge of the local language and very good knowledge of English.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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