KEDPLASMA provides a friendly and rewarding working environment with frequent opportunities for cross-training and advancement. Please apply if you meet any of the criteria described below, with relation to the job duties and responsibilities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status. Kedrion Biopharma & KEDPLASMA offer a number of benefits to qualifying employees, including: + Medical, vision and dental insurance + Life and AD&D insurance + Paid holidays + PTO accrual + and much more! If you would like further details regarding the benefits we offer please let us know, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have! **Job Scope / Job Mission** _We are seeking an experienced and highly motivated Senior Clinical Trial Assistant (CTA) to join our Clinical Operations team. This role is pivotal in supporting clinical trials from initiation to completion, ensuring all tasks are executed with precision and compliance. The ideal candidate will bring a combination of proven clinical trial support expertise, ability to lead management of the electronic trial master file, desire to expand their project management experience, and the ability to work independently in a fast-paced environment with minimal oversight in a sponsor setting._ We envision that the responsibilities of this role will be spread across the following areas, as indicated below: 40% Clinical trial support 30% Veeva management including training 20% Project management support 10% US functional/departmental support Main Responsibilities **Core Job Responsibilities** 1. **Clinical Trial Support** 2. Assist clinical development and operations personnel in the conduct of clinical studies. Key activities include but are not limited to: 3. Co-ordinate clinical trial support tasks during the study. 4. Lead practical arrangements on internal and external meetings and contribute to the preparation of study materials, presentations, minutes, and follow up items as required. 5. Produce and/or review study aids and clinical documentation/manuals e.g. Patient ID Cards, Diary Cards, Patient Information Sheets/Consent Forms and Newsletters for specified trials to a high quality standard. 6. Arrange for documents to be translated, where necessary. 7. Maintain project and trial management tools and ensure they are used efficiently within the team using Smartsheet or project management software. 8. Facilitate communication between study sites, vendors, and internal/externalteams. 9. Assist with ordering, tracking and return of clinical trial supplies. 10. Help with maintenance of invoice tracking logs and budget spreadsheets according to departmental standard operating procedures. 11. Support monitoring activities by assisting with the preparation and follow-up tasks as well as accompanying on site visits and liaising with sites, as required. 12. Support study close-out activities including preparation of study documentation for archive and collaborate with the Departmental Archivist to organize archiving in accordance with applicable SOPs, and reconciliation activities. 13. Preparation of documentation for departmental personnel by use of advanced knowledge of MS Office, Sharepoint, Smartsheet and MS Project. Learn new systems as required to assist departmental personnel. 14. Assist with data review, reconciliation and QC activities 15. Coordinate internal/external meeting planning 16. Budget and invoice reconciliation 1. **Trial Master File and Essential Document Management** 2. Coordinate and manage essential clinical trial documents, including Trial Master File (TMF) maintenance, ensuring completeness and compliance with Good Clinical Practice (GCP), SOPs, and regulatory requirements. 3. Perform administrative Trial Master File (TMF) management and maintenance activities in Veeva’s eTMF system. 4. Instruct and train clinical team and/or delegated third parties in the use of the eTMF 5. Prepare clinical trial documents in conjunction with clinical research personnel. 6. Co-ordinate regular interim internal Trial Master File QC checks. Trial Master Files must be audit / inspection ready at all times by regular filing and QC checks. 7. Create templates to standardize documentation for clinical trials, where required. 8. **Project Management** 9. Assist in planning and tracking timelines, budgets, and resources for clinical studies. 10. Monitor and ensure adherence to project plans and study protocols. 11. Track and manage study milestones, including patient enrollment, site activations, and study deliverables. 12. Support the Clinical Study Manager with risk identification, management and mitigation in adherence to project management best practice. 13. Maintain a fundamental understanding of clinical study management skills and knowledge 14. Support Project Leadership with tracking including but not limited to resource allocation, risk management, trend analysis and financial reporting 1. **Quality Assurance** 2. Support the Clinical Operations Team with quality assurance activities aimed at improving regulatory compliance. Examples include: 1. Spot checks on training records, job descriptions and CVs of clinical research personnel 2. Maintenance of compliance checks for clinical trials to ensure adherence to regulatory timelines e.g. annual safety updates, progress reports 3. Assist raising and managing Quality Management System (QMS) records in TrackWise and MasterControl software. 4. Assist Clinical Operations Management with preparation of the annual audit plans. 5. Support monitoring adherence to the audit plan in liaison with the clinical research personnel and GCP Auditor. Ensure all audit documentation is finalized and filed appropriately. 6. Assist the Global Clinical Development and Operations Department with activities prior to or during any MHRA inspections of Medical Department processes. 7. Assist the Clinical Operations Management during any QA checks/audits of clinical trial data/processes performed either in-house or at the request of a third party. 1. **Compliance** + Adhere to Good Clinical Practice and maintain training compliance + May assist with SOP development, review and tracking **Requirements (Education, Work Experience, Any specialty? # Years experience, Soft skills/Leadership)** + _Bachelor's degree in life sciences, healthcare or a related field with 3-5 years of relevant experience_ + _Direct experience setting up, managing, and training personnel in the Veeva Vault TMF is required._ + _Ability to demonstrate essential document completeness, compliance and accuracy_ + _Knowledge of clinical trial processes and ICH GCP guidelines._ + _Experience filing essential documents according to the DIA reference model._ + _Familiarity with using eTMF, EDC, IRT, CTMS, and other vendors systems/portals._ + _Clear and concise verbal and written communication skills and strong organizational skills._ + _Able to multi-task, prioritize, track projects, and follow through on time with assigned tasks._ + _Exceptional attention to detail._ + _Strong problem solving and analytical skills_ + _Able to work independently and in a matrix environment as part of a team._ + _Able to learn quickly and effectively using newly acquired skills._ + _Willingness to go beyond the scope of the job to help the department and organization achieve objectives._ + _Willingness to embrace change and work in a changing environment._ + _Able to work collaboratively across cultures and geographies._ + _Close to Durham, NC and willing to work on-site when required_ + _Proficient in Microsoft Outlook, Word, PowerPoint, and Excel_ All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.