.Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the Clinical Research Associate (CRA) conducts clinical trial site start-up activities related to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures.Your responsibilities will include:Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites.Manage multiple sets of essential regulatory documents across several studies and division portfolios.Partner with clinical sites to support the negotiation and customization of Informed Consent Forms (ICF).Develop and foster clinical research site relationships to become a subject matter expert in the site start-up regulatory process across multiple studies.Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives.Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking.Manage and problem solve site start-up challenges that arise to mitigate impact to service level agreement and study goals.Develop, prepare, complete and track required regulatory, ICF and legal documentation.Document clinical research site and investigator readiness for participation across multiple studies.Support internal quality audits, regulatory inspections, as applicable.Update and maintain study-specific startup and close-out trackers.Update and maintain site-specific metrics in Clinical Trial Management Systems, file and maintain site documents in eTMFs.Provide updates to leadership on site start-up activities, investigator readiness, regulatory submission, approval status, etc.Escalate challenges and/or initiate outreach to Principal investigators, clinical research site coordinators, divisional clinical study leads and/or other stakeholders when appropriate.Ensure compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WI, policies & procedures.What are we looking for in you:Successfully completed degree studies (or equivalent) within a relevant scientific or healthcare subject.Fluent language skills (both verbal and written) in English and German. Additional languages are beneficial.Previous experience within Clinical Research is beneficial, such as:Study submissions to the Ethics Committee.Experience as a Research Coordinator, In-House CRA, CRA, or Study Start-Up Specialist.Experience with Clinical Trial Management systems (e.G., Siebel CTMS, Veeva, etc.) and clinical document control systems / eTMF.Strong communication skills and comfortable interacting with clinical research site personnel via phone, email, and in-person
