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Clinical Research Associate (CRA)

Location
Serbia
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Job Description

As a Clinical Research Associate you will be responsible for a variety of monitoring tasks and you will have a chance to work on clinical studies in different therapeutic indications, ensuring the clinical trial is conducted in compliance with study protocol and procedures, ICH-GCP guidelines and the applicable regulations and SOPs.

Main duties and responsibilities

  • Initiate, monitor and close-out clinical studies on study sites in accordance with applicable regulations, guidelines of ICH-GCP and standard operation procedures;
  • Prepare and perform regulatory and ethics submission (drug, medical device, non-interventional) for approval in accordance with applicable regulations, guidelines of ICH GCP and standard operation procedures of HungaroTrial (e.g. able to perform initial CA and EC submissions, amendment, notification, progress and safety report submissions, contract negotiations without direct supervision);
  • Support contracting procedure between Sponsor and Investigational sites;
  • Perform feasibilities and pre-study evaluations;
  • Document activity in accordance with ICH-GCP and standard operation procedures of HungaroTrial;
  • Prepare a summary (report) of activities as requested by the Manager.
Requirements
  • Bachelor degree in life sciences
  • at least 2 years (preferable more) experience in clinical research
  • Fluency in English and Serbian
  • Confident IT skills
  • Driver’s license
  • effective communication, customer focus, teamwork, time management, motivation to learn and develop

What we can offer:

  • Dedicated and supportive team
  • Multinational environment
  • Regular team buildings and company events
Employment form
full-time

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