Clinical Trial Associate I (eTMF)

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 Biotech™. Join us and build your future here.

What You’ll Be Doing

• Assists in eTMF (electronic Trial Master File) filing and administration by submitting documents and/or files, conducting document review, supporting document query resolution, ensuring completeness, and conducting final site level review along with final document collection
• Supports study team with functionality and use of TMF in accordance with study-specific TMF Plan, SOPs, and study-specific processes
• Identifies, manages, escalates where appropriate, and resolves site issues effectively
• Create and maintain tracking tools and database repositories for operational data including
• Tracks non-TMF documents and study status in applicable tracking system
• Reports document collection and tracking issues to functional lead and/or study team

What We Are Searching For

• Bachelor’s degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience
• 0 to 2 years of practical experience with clinical trial administration (e.g. – Inhouse CRA, CTA, site administration, clinical monitoring) preferred
• Experience with eTMF document uploading highly preferred, particularly in Veeva Vault.
• Demonstrates excellent English verbal and written communication skills

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $45,000 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status