Clinical Trial Associate

Clinical Trial Associate

Premier Research

Sofia, Bulgaria

What You’ll Be Doing:

• Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF).
• Reviews site documents and verifies they meet or exceed all company, sponsor, regulatory authority, and ALCOAC standards.
• Performs completeness checks of relevant eTMF sections in compliance with company or Sponsor processes throughout start up, maintenance, and close out activities and ensures follow up with clinical team of resolution of findings.
• Conducts follow up with the internal team on TMF queries to ensure timely resolution.
• Routinely runs and distributes eTMF reports to clinical team to facilitate quality and compliance.
• Assists the clinical team with CTMS set up and data entry into project tracking systems.
• Reviews the project specific training matrices and reports to ensure compliance of clinical team.
• Attends internal clinical meetings as required and assists with meeting preparation and follow up.
• Supports the CRA/clinical team in liaising with third party vendors to solve and follow-up on issues e.g. on study equipment, translations.
• Assists the clinical team with the development of study materials.

What We Are Searching For:

• Undergraduate degree required, or its international equivalent in nursing, life sciences or medical documentation from an accredited institution.
• Knowledge of ICH/GCP preferred.
• Solid computer knowledge/skills including MS Word, Excel, PowerPoint and Outlook.

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