Clinical Trial Associate II (TMF Specialist)

Premier Research

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About The Position

Premier Research is looking for a Clinical Trial Associate II (TMF Specialist) to join our Functional Services Provider (FSP) 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. 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. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

Requirements

• 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
• 2 to 5 years of practical experience with clinical trial administration (e.g. – Inhouse CRA, CTA, site administration, clinical monitoring) preferred
• Strong knowledge of clinical studies and ability to support study team with functionality and use of TMF in accordance with study-specific TMF Plan, SOPs, and study-specific processes
• Strong communication and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities

Nice To Haves

• Preferred Location: East Coast

Responsibilities

• 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
• Creates and maintains tracking tools and database repositories for operational data including Key Performance Indicators (KPIs) and quality metrics
• Participates in project team meetings, prepares meeting minutes, and maintains action/decision logs
• Reports document collection and tracking issues to functional lead and/or study team, and assist more junior CTA team, as required
• Maintains clinical inspection readiness and supports regulatory inspections and/or audits as required

What This Job Offers

• Career Level: Mid Level