To provide general project and administrative support to the Clinical and Regulatory Teams in Europe.Primary Responsibilities· To assist the EU Clinical and Regulatory teams in completion of all required tasks to meet departmental goals and objectives.· To support the EU Clinical and Regulatory teams with study start-up, site activation and ongoing conduct of clinical studies.· To be familiar with ICH GCP, appropriate regulations, and relevant SOPs.· Perform QC check of study documents and filing of all essential study documents in the Trial Master File (TMF). Knowledge of DIA TMF Reference Model and eTMF systems will be preferred.· Maintain clinical site information in appropriate contact lists and distribution lists.· To set up, organize and maintain clinical study documentation (e.g. Main Study Files and Trackers, etc.) including preparation for internal/external audits, final reconciliation and archival.· To support preparation of essential documents for submission to IRB/EC and Competent Authorities.· To coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs/worksheets, diaries, patient cards, lab supplies, IRF binders, patient binders, etc.) to study sites.· To assist study team with trial progress tracking by updating Project Plans and project trackers.· To assist in coordination of Investigator, Clinical site, and vendor payments. Setup and QC site invoices with EDC reports for payment requests and update in project trackers.· To act as a back-up to CRAs for site requests (e.g., missing documentation, meeting arrangements).· To coordinate document(s) translation, as needed. Support QC review of translated documents· To attend study team meetings and support generation of meeting minutes & filing.· To assist in organizing telephone conferences, video calls, Investigator Meeting coordination, activities preparation and generation of meeting minutes.· To assist in the production of slides, as needed for study presentations.· Support study close out activities (eg. archiving, shipments of CDROMs to sites, etc.).· Support study inventory/equipment tracking and management (eg. BP devices, lab kits, etc.).· Assist CRAs in preparation or follow-up of on-site monitoring visits as needed.Supervisory Responsibilities· NoneEducation Requirements· Bachelor's Degree preferred but relevant research experience or biomedical training may be substituted. Experience: · 2 years of clinical trial or relevant research experience. Knowledge:· Knowledge and ability to produce documents in Microsoft Word, Excel, PowerPoint, internet access and web-based navigation skills. Knowledge of EDC, CTMS, and MS project an advantage. SkillsHigh attention to detail and accuracy.Candidate should have demonstrated ability to work independently in a remote team setting.Ability to communicate and interface with department and senior management.Strong initiative and positive attitude with clear and concise verbal and writing skills.Excellent interpersonal skills, including problem solving/decision making skills.Ability to manage and prioritize multiple tasks and remain focused on personal objectives with minimal direction.Strong interpersonal communication skills with the ability to effectively communicate across all levels.Physical Demands and Conditions Requirements· General office environment.Equipment Used· General office equipment.