Assistant Cra

thermofisher

📍 milan italy bologna italy rome italy italy🕐 1mo ago🔗 workday

Job Description

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Join Us as an Assistant Clinical Research Associate – Make an Impact at the Forefront of Innovation** ======================================================================================================= **What You'll Do** ------------------ ### Study & Site Support * Complete assigned study and site management activities in accordance with the study task matrix. * Complete required study-specific training and become proficient in relevant study systems. * Provide in-house support for pre-study assessments and related activities. * Support the customization and maintenance of site-specific documentation, including informed consent forms (ICFs), as required. * Support remote review and collection of applicable site assessments and documentation. * Verify document collection and submission status and ensure site information remains accurate and up to date. * Support the collection, review, and maintenance of Essential Documents in applicable clinical systems. * Follow up on missing, incomplete, or expired documentation and support resolution of outstanding document findings. ### Site Coordination * Support investigational sites throughout study start-up, activation, ongoing management, recruitment, and close-out activities, as assigned. * Assist site staff with vendor qualification processes where applicable. * Coordinate requests for study system access for relevant site staff and support access maintenance throughout the study. * Follow up on required site staff training. * Coordinate and support logistics for investigator meetings and other study activities. * Support study and site supply management throughout the study lifecycle. * Maintain study and vendor trackers as assigned. ### Study Monitoring & Data Support * Support ongoing remote review of centralized monitoring tools and study dashboards. * Follow up on missing study vendor data, such as ECGs, laboratory samples, and electronic diaries, as directed. * Perform reconciliation activities across assigned studies, including CRF and query status, protocol deviations, SAEs, and safety reports, as applicable. * Extract and review relevant information from study documentation, electronic study data systems, CTMS, and dashboards. * Support CRAs and Clinical Leads with additional site management and remote monitoring activities as assigned. ### Site Payments & Administration * Support site payment processes by coordinating with investigational sites and internal functional teams. * Assist with system updates, payment reconciliations, and follow-up on site invoices throughout the study. * Complete administrative activities, including timesheets and expense reports, accurately and on time. * Contribute to other study-specific activities according to project and client requirements. **What We're Looking For** -------------------------- ### Minimum Qualifications * Bachelor's degree in a **life sciences discipline or related field**, Registered Nursing qualification, or equivalent relevant academic/vocational qualification. * **0–2 years of relevant professional experience**, making this an excellent opportunity for candidates looking to develop their career in clinical research. * Equivalent combinations of education, training, and directly related experience may also be considered. ### Preferred Skills & Experience * Basic understanding of medical terminology and therapeutic areas. * Interest in developing a strong working knowledge of **ICH-GCP**, applicable regulations, and clinical research procedures. * Excellent written and verbal communication skills. * Excellent interpersonal skills and a strong customer-focused approach. * Strong organizational and time-management skills with excellent attention to detail. * Ability to manage multiple tasks efficiently and effectively. * Strong critical thinking and problem-solving capabilities. * Flexible and adaptable approach to changing priorities and project requirements. * Ability to work effectively both independently and as part of a cross-functional team. * Proficiency in Microsoft Office and confidence in learning new clinical trial systems and digital tools. * Ability to work with study documentation, electronic clinical systems, CTMS platforms, and dashboards. * **Excellent English language skills**, both written and spoken. **Working Environment & Travel** -------------------------------- This position is primarily performed in an **office or home-office environment**, depending on business requirements. * The Assistant CRA role **does not involve regular travel**. * Occasional travel to clinics, hospitals, or other study locations may be required. * The position provides valuable experience and development opportunities for those interested in progressing within the CRA career path. * Please note that future CRA positions typically involve significantly more travel, often approximately **60–80%**, depending on the role, project, and business requirements. **Why Join Thermo Fisher Scientific?** -------------------------------------- When you join Thermo Fisher Scientific, you become part of a global team committed to accelerating scientific discovery and improving patient outcomes. We offer: * An excellent opportunity to **start or develop your career in clinical research**. * Exposure to innovative global clinical trials and international project teams. * The opportunity to learn from experienced CRAs and clinical research professionals. * Structured learning and opportunities to build your clinical operations expertise. * A collaborative and inclusive working environment. * Professional development and opportunities for career progression. * Competitive compensation and benefits. * The opportunity to contribute to clinical research that can make a meaningful difference in patients' lives. If you're detail-oriented, motivated to learn, and excited about building a career in clinical research, we'd love to hear from you. **Apply today and help us deliver tomorrow's breakthroughs.**
Assistant Cra at thermofisher | MergeJobs