- Location
- Italy - Milan - Building Y, Segreen Business Park, Via San Bovio 1/3 · Bologna, Italy · Rome, Italy
- Workplace
- Hybrid
- Type
- Full-time
- Education
- Bachelor
- Source
- Workday
Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.