Premier Research is looking for a Clinical Trial Associate III, Sponsor-dedicated (contract) 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.
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
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 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
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
This is a 12-month 1099 contractor position with the potential to extend and renew after 1 year.
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