Senior Clinical Research Associate

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) dedicated to partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. With expertise in full-service capabilities, resourcing, and Functional Service (FSP) solutions, we’re looking for a talented Clinical Research Associate (CRA) contractor to join our team in Italy.

About the Role

As a Senior Clinical Research Associate with TFS HealthScience, you will be a vital part of our SRS/FSP team, working exclusively with a global biotech sponsor. You will play a crucial role in ensuring the quality and integrity of clinical trials, driving them forward from start to finish.

Key Responsibilities

• Submission & Amendment Support: Assist with initial and ongoing submissions, including amendments to ethics committees.
• Regulatory Reporting: Manage periodic reporting to ethics committees, including the reporting of safety events.
• Pre-activation & SIV Support: Contribute to site pre-activation activities and support Site Initiation Visits (SIVs).
• Monitoring & Site Management: Conduct both onsite monitoring and periodic central monitoring to ensure trial integrity; manage site relationships and processes.
• Documentation & Closeout: Maintain the eTMF (electronic Trial Master File) and lead closeout visits, ensuring compliance and completeness.

Qualifications

• Experience: Minimum of 5 years of clinical monitoring experience within a CRO, biotech, or pharmaceutical environment.
• Education: A Bachelor’s degree in a related field (Life Sciences, Nursing, etc.).
• Regulatory Knowledge: Strong understanding of ICH-GCP guidelines and regulatory requirements in Italy.
• Technical Skills: Proficiency in clinical trial management systems (CTMS) and eTMF platforms.
• Communication: Excellent written and verbal communication skills with the ability to interact effectively with site staff and sponsor representatives.

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for both personal and professional growth within a supportive and rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a real difference in the lives of patients.

Why TFS HealthScience?

Founded over 27 years ago in Lund, Sweden, TFS HealthScience has grown into a full-service, global CRO with over 800 professionals across more than 40 countries. We specialize in providing flexible clinical development and strategic resourcing solutions across key therapeutic areas, including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values—Trust, Quality, Passion, Flexibility, and Sustainability—are the foundation of everything we do. These values guide our decisions at all levels and help us attract and retain top talent who share our commitment to excellence. Together, we foster a culture of innovation, mutual respect, and collaboration, driving us towards a healthier future for all.

Make a Difference with Us

Join TFS HealthScience and be part of a team that’s making a real impact on global health. Apply now to take the next step in your career!