Premier Research is looking for a Clinical Trial Associate to join our Global Clinical Monitoring and Site Management team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
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We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
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We are Built by You. Your ideas influence the way we work, and your voice matters here.
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We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
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Together, we are Built for Biotechâ„¢. Join us and build your future here.
What You’ll Be Doing:
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Maintaining Trial Master File (TMF)/electronic Trial Master File (eTMF).
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Creating and maintaining placeholders in the TMF based on TMF filing plans, expired documents, study milestones, site staff changes, and other applicable events.
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Reviewing site documents and verifying they meet or exceed all company, sponsor, regulatory authority, and ALCOAC standards.
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Performing 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.
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Conducting follow up with the internal team on TMF queries to ensure timely resolution.
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Routinely running and distributing eTMF reports.
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Assisting with managing and tracking access to systems
What We Are Searching For:
•   Undergraduate degree, 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.
This position will be offered with a hybrid set up; 2 days from home and 3 days from our Sofia office, for at least the duration of the training / on-boarding period (estimated to be 3 months). After this time, there may be a review, however, there is no guarantee it will become a fully remote position.