Senior Clinical Research Associate - Oncology/Hematology - Italy

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.

Make an Impact as a Senior Clinical Research Associate Italy at Worldwide

As a Senior Clinical Research Associate, you’ll play a key role in protecting patient safety and ensuring the quality and integrity of clinical trial data. You’ll take ownership of site activities throughout the study lifecycle, from qualification and initiation through ongoing monitoring and close-out.

Beyond your own sites, you’ll have opportunities to contribute as a Lead CRA on global studies, coordinate and support other CRAs, and provide mentoring and guidance to less experienced colleagues and site staff. You’ll work closely with Project Management, investigators, and study teams to keep studies compliant, well managed, and aligned with key milestones.

You’ll also bring your monitoring expertise to wider study activities, contributing to monitoring plans, study tools, training, investigator meetings, bid defenses, and protocol and CRF design when required.

Where You'll Work

This is a home-based Clinical Research Associate role supporting sites across Italy. Candidates must reside within the territory to effectively support site visits and study activities. You will collaborate with sites, sponsors, and global study teams while traveling to investigative sites approximately 6-8 days per month.

What You'll Do

• Lead site qualification, initiation, interim monitoring, management, and close-out activities in accordance with study protocols, GCP, applicable regulations, and SOPs.
• Safeguard patient safety and data quality through informed consent review, source document verification, CRF review, safety information oversight, and timely data query resolution.
• Partner with study teams, Project Management, investigators, and site staff to monitor deliverables, study milestones, protocol adherence, and overall site performance.
• Coordinate CRAs as a Lead CRA on global studies and provide mentoring, training, accompanied visits, and practical guidance to colleagues and site teams when required.
• Ensure essential regulatory, ethics, site, and TMF documentation is complete, current, and appropriately maintained throughout the study.
• Manage site-level study requirements, including study material coordination, Investigator Site File maintenance, and investigational product receipt, accountability, return, or destruction.
• Document monitoring findings through clear, timely visit reports and review site visit reports prepared by other CRAs, providing constructive feedback and edits.
• Contribute to Clinical Monitoring Plans, study-specific tools and templates, protocols, CRFs, training, investigator meetings, and bid defenses as requested.
• Maintain effective communication with sites and study stakeholders, helping resolve issues and supporting consistent delivery throughout the study lifecycle.

What You'll Bring

• An MD or Pharmacy degree (MSPH, PharmD, PhD, or equivalent Pharmacy qualification) with at least 3 years of CRA experience; or a four-year degree with a major concentration in medical, biological, physical, health, pharmacy, or another related science with at least 5 years of CRA experience; or a two-year college curriculum or equivalent education/training, preferably in nursing or life sciences, with at least 7 years of CRA experience.
• Extensive knowledge of clinical research, including GCP, FDA and/or EU regulations and directives, ICH Guidelines, local regulatory requirements, SOPs, monitoring, and site management activities.
• Strong therapeutic-area knowledge, with a thorough understanding of two to three therapeutic areas sufficient to operate as a Lead CRA where appropriate.
• Proven communication, planning, organization, interpersonal, problem-solving, and time-management skills, together with the ability to lead and motivate an assigned team where applicable.
• Proficiency with Microsoft Office, IxRS, and electronic data capture systems.
• A valid current passport and driving licence, together with willingness to travel.
• Fluency in the local languages of the countries under your responsibility and proficiency in spoken and written English.
• Experience in full-service monitoring PREFERRED

Discover the Difference

We love knowing that someone is going to have a better life because of the work we do.  Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.

About Us

This is who we are.

We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever.

We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.