Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
We're looking for a Clinical Research Associate II (CRA II) to join our growing Clinical Operations team in Italy. If you're passionate about clinical research, enjoy building strong site relationships, and want to contribute to studies that make a real difference for patients worldwide, we'd love to hear from you.
What You'll Do
As a CRA II, you'll be responsible for monitoring clinical trial sites and ensuring studies are conducted in compliance with protocols, ICH-GCP guidelines, applicable regulations, and company SOPs.
Your responsibilities will include:
- Conducting on-site and remote monitoring visits using a Risk-Based Monitoring (RBM) approach.
- Ensuring subject safety, data integrity, and protocol compliance.
- Performing Source Data Verification (SDV), Source Data Review (SDR), and CRF review.
- Assessing investigational product accountability through inventory and documentation reviews.
- Identifying site issues, performing root cause analysis, and implementing corrective and preventive actions (CAPA).
- Preparing high-quality monitoring reports and ensuring timely follow-up of action items.
- Supporting site initiation, routine monitoring, and close-out visits.
- Reviewing essential documents to ensure compliance with ICH-GCP and regulatory requirements.
- Maintaining study documentation and updating clinical trial management systems (CTMS).
- Building collaborative relationships with investigators, site staff, sponsors, and cross-functional project teams.
- Supporting audit and inspection readiness throughout the study lifecycle.
- Participating in investigator meetings and contributing to process improvement initiatives.
- Completing administrative activities, including expense reports and timesheets, accurately and on time.
What We're Looking For
Required Qualifications
- Master's degree in Life Sciences or an equivalent scientific qualification.
- Approximately 1+ year of clinical monitoring experience as a Clinical Research Associate or equivalent.
- Good knowledge of ICH-GCP guidelines and applicable clinical research regulations.
- Valid driver's license.
- Fluency in Italian and English, both written and spoken.
Skills & Competencies
We're looking for someone who brings:
- Strong clinical monitoring experience.
- Solid understanding of clinical trial processes and medical terminology.
- Knowledge of Risk-Based Monitoring principles.
- Excellent analytical thinking and problem-solving skills.
- Ability to identify root causes and proactively resolve issues.
- Strong communication and relationship-building skills.
- High attention to detail and commitment to quality.
- Excellent planning, organization, and time management abilities.
- Customer-focused mindset with the ability to collaborate across diverse teams.
- Flexibility and adaptability in a dynamic environment.
- Proficiency in Microsoft Office and clinical systems.
Working Environment
This role offers flexibility with a combination of home office, office, and clinical site-based work.
The position requires:
- Frequent travel to investigator sites across Italy.
- Regular driving.
- Occasional overnight stays.
Why Join Thermo Fisher Scientific?
When you join us, you'll become part of a global organization dedicated to enabling our customers to make the world healthier, cleaner, and safer.
We offer:
- The opportunity to work on innovative global clinical trials.
- A collaborative and supportive international environment.
- Ongoing professional development and career growth.
- Exposure to leading pharmaceutical and biotechnology sponsors.
- A culture that values inclusion, innovation, and excellence.
If you're ready to advance your CRA career while contributing to research that changes patients' lives, we'd love to hear from you.
Apply today and make your impact with Thermo Fisher Scientific.
