Site Start up Associate II

Premier Research is looking for a Site Start up Associate II to join our Global SSU 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: Preparing and submitting Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Preparing ongoing submissions, amendments, and periodic notifications (including safety reporting). Performing essential document collection and review. Local Investigator Contract and Budget Negotiator - producing site-specific contracts from country template. Submitting proposed contract and budget to the site for review. Negotiating budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution. Conducting the site identification/feasibility process on a country level. Preparing Investigational Product (IP) checklist according to country regulations. Ensuring accuracy and completeness of Trial Master File documents submitted throughout the study and performs a QC review of files for which Start-up Associate is acting as document owner. What We Are Looking For: Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional. Proven experience as a Site Start Up Associate I and/or 5+ years of related clinical trials experience, including at least 3 years of experience in the submission of clinical trial applications via CTIS. Submissions will be mainly interventional IMP studies. Experience working on different study types/phases such as non-interventional studies, medical device studies, GMO studies, and observational studies etc. an advantage. Experience in contract and budget negotiation with sites Working knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155 regulations, drug / device development and clinical monitoring procedures. This is a contract position, offered initially as a 6-month duration and a 0.75 FTE. 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.