Site Start up Associate II

Job description

Premier Research is looking for a Site Start up Associate II to join our Regulatory Submissions and Contracts 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.