CRA (Level II)

ThermoFisher Scientific; Italia; Hybrid; EUR 42,000 - 58,000; Full time

Job summary

Thermo Fisher Scientific in Italy is seeking a Clinical Research Associate II to join our Clinical Operations team. This role focuses on monitoring trials and building strong site relationships to ensure studies meet ICH-GCP standards.

You will conduct on-site and remote visits, perform SDV/ SDR, review essential documents, and drive CAPA actions while collaborating with investigators, sponsors, and cross-functional teams across Italy. Travel is required.

Qualifications

• Master's degree in Life Sciences or equivalent.
• 1+ year of clinical monitoring experience.
• Fluency in Italian and English (written and spoken).

Responsibilities

• Conduct on-site and remote monitoring visits using a Risk-Based Monitoring (RBM) approach.
• Ensure subject safety, data integrity, and protocol compliance.
• Perform Source Data Verification (SDV), Source Data Review (SDR), and CRF reviews.
• Assess investigational product accountability through inventory and documentation reviews.
• Identify site issues, perform root cause analysis, and implement CAPAs.
• Prepare high-quality monitoring reports and ensure timely follow-up of actions.
• Support site initiation, routine monitoring, and close-out visits.
• Review essential documents to ensure ICH-GCP compliance and regulatory requirements.
• Maintain study documentation and update CTMS.
• Build collaborative relationships with investigators, site staff, sponsors, and cross-functional teams.

Skills

Clinical monitoring

Regulatory knowledge

Communication

Time management

Analytical thinking

Education

Master's degree in Life Sciences

Tools

Microsoft Office

Clinical systems

Job description

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.