Assistant CRA

Over deze vacature

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 DoStudy & 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 ForMinimum 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 & TravelThis 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.