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JR CLINICAL RESEARCH ASSOCIATE

We're looking for a Junior Clinical Research Associate who will manage and monitor the conduction of clinical studies and compliance to the protocol requirements with established timelines. He/ she will be involved in all stages of the clinical study, including initiating, monitoring and closing down the study.

Major Accountabilities:

  • Gain experience in study procedures by working with experienced clinical staff.
  • Support the other CRAs (or manage entirely) during the preparation of the study documentation for the Ethics committee and/or other required Competent Authorities submissions to ensure successful outcome.
  • Under close supervision, organize & perform the Site Initiation Visit: prepare and send the ISF and patients binders, train the study staff to the study-specific activities.
  • Monitor the study throughout its duration, which involves both remote monitoring and on-site visits at the study sites on a regular basis.
  • Verify data entered for consistency with original data source, track completed CRFs and timely respond to queries and requests.
  • Liaise and communicate with study staff on conducting the trial.
  • Maintain and update Clinical Master file and the essential study documentation.
  • Analyze data, discuss results and prepare monitoring visit reports/clinical presentations.
  • Organize and/or participate in kick-off and Investigator Meetings to review progress of ongoing clinical studies.
  • Review AEs and ensure adequate communication to the NCA according to procedures.

Here a description of a good candidate:

  • Academic education in Life Sciences or Medical Sciences (Biological Science, Pharmacy, Biomedical Engineering or other health-related discipline preferred)
  • English fluent
  • Accuracy
  • Analytical Thinking
  • Effective communication
  • Availability to travel (20-30%)

 

Degrees of interest: Academic education in Life Sciences or Medical Sciences: Biological Science, Pharmacy, Biomedical Engineering

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