Regulatory Affairs Experte

Rahmendaten

<p><strong><strong>Rahmendaten</strong></strong>: </p> <ul> <li>Laufzeit: 5 Monate ( Option auf Verlängerung) <li>Auslastung: 10h- 20h Woche  <li>Einsatzort: 100% remote <li>Starttermin: ASAP </ul>   <h3>Project Background:</h3> <ul> <li><strong>Study Focus</strong>: Data is being collected for a register study (STAR)  <li><strong>Scope</strong>: Started in September 2021 in Germany and has now expanded to multiple countries. <li><strong>Objective</strong>: Expanding the project to Northern Ireland and submitting an ethics application. </ul> <h3>Key Points:</h3> <ol> <li><strong>Register Study</strong>: Involves collecting routine data and does not involve any direct intervention. <li><strong>Expansion to Northern Ireland</strong>: Ethics approval is needed, and submissions must be made to local ethics committees and regulatory bodies. <li><strong>Platform for Submission</strong>: IRAS (Integrated Research Application System) is used in the UK, specifically for planning and improving research submissions. <li><strong>Current Status</strong>: There is existing ethics approval in place for England, Scotland, and Wales from IRAS, but it's uncertain whether the approval can be extended or a new submission is required. </ol> <h3>Tasks for the Candidate:</h3> <ul> <li><strong>Primary Task</strong>: Submitting the STAR Register to the ethics committee in Northern Ireland. <li><strong>Key Requirements</strong>: Familiarity with Northern Ireland’s regulatory landscape and how to submit documents via the appropriate online platforms (like the HRA and IRAS systems). </ul> <h3>Project Phases:</h3> <ul> <li>The project is still in the ethics submission phase for Northern Ireland, with active expansion efforts underway. </ul> <h3>Candidate Criteria:</h3> <ul> <li><strong>Language</strong>: English. <li><strong>Regulatory Knowledge</strong>: Expertise in Northern Ireland's regulatory requirements and ethics submissions. <li><strong>Platform Experience</strong>: Familiarity with IRAS and HRA submission platforms ( nice to have) </ul>