Senior Clinical Research Associate

3 giorni fa

Roma, Lazio, Italia Worldwide Clinical Trials Tempo pieno

Who We Are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

Who We Are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands‑on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us

Make an Impact as a Clinical Research Associate at Worldwide

As a Clinical Research Associate at Worldwide, you’ll play a critical role in ensuring the quality, integrity, and success of clinical trials. By partnering closely with investigative sites, study teams, and sponsors, you’ll help drive high‑quality data collection while supporting patient safety and regulatory compliance throughout the clinical research process.

In this role, you’ll take ownership of site management activities across the study lifecycle, from feasibility and site initiation through monitoring and close‑out. Your expertise will contribute to the successful delivery of clinical research programs while building strong relationships with site personnel and cross‑functional teams.

You’ll also have the opportunity to provide guidance to colleagues, contribute to study planning activities, and support operational excellence across global clinical trials.

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.

To best support our sites, we’re seeking candidates who are based in Italy. Travel will primarily be national, with occasional travel to support sites in other locations as needed.

What You’ll Do

  • Conduct site qualification, initiation, monitoring, and close‑out visits in accordance with protocol requirements, GCP, and applicable regulations.
  • Assess site performance and provide training and guidance to site personnel to promote protocol adherence, data quality, and patient safety.
  • Perform source document verification and review study data to ensure accuracy, completeness, and compliance.
  • Support regulatory and ethics documentation activities, ensuring study files remain inspection‑ready and up to date.
  • Partner with study teams and project management to track study progress, support milestones, and drive successful trial execution.
  • Maintain strong relationships and regular communication with investigative sites, sponsors, and cross‑functional stakeholders.
  • Review and document site findings, support query resolution, and contribute to Trial Master File and Investigator Site File maintenance.
  • Provide leadership and mentorship to less experienced CRAs and contribute to study‑specific tools, training initiatives, and operational improvements.

What You’ll Bring

  • Medical Doctor (MD) degree or Pharmacy degree with a minimum of 3 years of Clinical Research Associate experience; OR a bachelor's degree in a life science or related field with a minimum of 5 years of CRA experience; OR a nursing/associate degree or equivalent with a minimum of 7 years of CRA experience.
  • Strong clinical monitoring experience across the full study lifecycle, including site qualification, initiation, monitoring and close‑out activities.
  • Thorough understanding of GCP, ICH Guidelines, FDA and/or EU regulations, and local regulatory requirements.
  • Demonstrated knowledge of clinical research processes, site management practices, and regulatory documentation requirements.