Premier Research is looking for a Clinical Trial Associate to join our Monitoring team in Sofia, Bulgaria.
This position will be offered as a hybrid set up (3 days in the office / 2 days from home) during the on-boarding / training period (anticipated 3 months) after which, there may be the opportunity for more flexibility for home-working.
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.
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.
We are Built by You. Your ideas influence the way we work, and your voice matters here.
We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
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
Why Choose Premier Research?
Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly.
Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
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