Creative Pharma Services S.A
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Main Responsibilities

The responsibility of a Clinical Research Associate (CRA) in Interventional Clinical Trials (phase II-III) is to prepare the submission files and perform the clinical monitoring aspect of designated projects in accordance with applicable ICH-GCP guidelines, SOPs and international / national regulations.

Responsibilities also include performing qualification, initiation, monitoring and close-out of investigational sites. Specifically :

  • Show solid understanding of therapeutic indications and study hypothesis
  • Build relationships with investigators and site staff
  • Communicate effectively with the other study team members at local and global level
  • Prepare submission files to Hospitals, National EC and HA
  • Arrange and perform on-site visits in accordance with the monitoring plan
  • Conduct on-site study-specific training (if applicable)
  • Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
  • Perform site facilities inspection
  • Ensure completeness and quality of the on-site files
  • Update all relevant tracking system on an ongoing basis
  • Write the relevant visit / contact report in accordance with monitoring plan
  • Attend Audits / Regulatory Inspection if requested
  • Αναφορά αυτής της εργασίας

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