Clinical Trial Associate III (Contract)

Premier Research

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About The Position

Premier Research is looking for a Clinical Trial Associate III (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. Premier Research is dedicated to providing compensation that is fair and competitive with market standards. 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. 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 Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. 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. Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests. Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.

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
• 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
• Number of Employees: 251-500 employees