SSU II

<p><b>Responsibility: </b></p><ul><li>Delivery of the Study Start Up (SSU) component of assigned studies within a country or globally. Including accountability for delivery to time, cost and quality for assigned activities.</li><li>Primary contact with investigative sites during site start-up activities.</li><li>Responsible for working with investigative sites to collect the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor.</li><li>Responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial. Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials.</li><li>Where applicable, provide logistical support of clinical trial supply coordination.</li></ul><p></p><p><b>Position Expectation:</b></p><ul><li>This position will take <u>Site Contract Lead role</u> for months and will move to SSU team afterwards.</li><li>Site Contract Lead role will negotiate financial and legal aspects of CTAg and Master Service Agreements with sites, Institutions or vendor personnel.</li><li>Communicates clearly and efficiently with Clinical and Legal Teams regarding amendments and other issues.</li></ul><p></p><p><b>Job requirements:</b></p><ul><li>University degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) </li><li>At least 2 year experience as SSU.</li><li>Expected a smart and flexible candidate with good communication skill.</li><li>Good English skill, needs to communicate globally.</li></ul><p></p><p><b>Labcorp is proud to be an Equal Opportunity Employer:</b></p><p></p><p>As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.</p><p></p><p>For <span>more information about how we collect and store your personal data, please see our </span><span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank">Privacy Statement</a></span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank"><span>.</span></a><span> </span></p>