Clinical Research Associate - Italy - Remote
Worldwide Clinical Trials · Rome, Latium, Italy
- Hybrid
- Full-time
- $75,000 / year
- Rome, Latium, Italy
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Job highlights
- Manage clinical research sites for observational studies.
- Oversee study start-up, maintenance, and close-out.
- Ensure regulatory compliance and data accuracy remotely.
- Require strong organizational and communication skills.
- 2+ years CRA experience needed.
About the role
About Worldwide Clinical Trials
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!
What Clinical Operations Does At Worldwide
At Worldwide Clinical Trials, we invite you to embark on a rewarding journey within Clinical Operations, where your contributions will leave a profound impact on the lives of patients. As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases. Collaboration with top-tier colleagues from various backgrounds and specialties is not just encouraged; it's ingrained in our culture. Our commitment to advancing clinical research is nurtured within a supportive and team-oriented environment. In a CRA role, you'll receive extensive support through regulatory submissions, TMF management, and in-house CRAs for projects with heavy site management needs.
What You Will Do
- Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects, which are predominantly registries and other types of non-interventional / observational studies.
- Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded.
- Conduct study initiation visits (SIVs).
- While most of the site management efforts will be performed remotely, will be required to ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirements.
What You Will Bring To The Role
- Excellent interpersonal, oral, and written communication skills in English.
- Superior organizational skills with attention to details.
- Ability to work with little or no supervision.
- Proficiency in Microsoft Office, CTMS and EDC Systems.
Your Experience
- 2+ years of experience as a Clinical Research Associate.
- 4-year university degree or RN/BSN in Nursing.
- Please submit English resume.
- Willingness to travel required.
Key skills/competency
- Clinical Research Associate
- Regulatory Submissions
- TMF Management
- Site Management
- Data Collection
- Safety Reporting
- Informed Consent
- Clinical Study Start-up
- Non-interventional studies
- Observational studies
Skills & topics
- Clinical Research Associate
- Clinical Operations
- CRO
- Regulatory Affairs
- Site Management
- Data Management
- Clinical Trials
- Observational Studies
- Nursing
- Healthcare
How to get hired
- Tailor your resume: Highlight your 2+ years of Clinical Research Associate experience and nursing qualifications. Emphasize skills in site management, regulatory submissions, and data collection.
- Showcase attention to detail: During the application process, meticulously fill out all required fields and ensure your English resume is flawless.
- Prepare for remote work: Be ready to discuss your ability to work independently and manage site activities remotely, ensuring compliance and reporting.
- Highlight travel willingness: Confirm your willingness to travel as required for the Clinical Research Associate role during your application or initial screening.
- Research Worldwide's mission: Align your application and interview responses with Worldwide Clinical Trials' mission to improve lives and their commitment to innovation and patient care.
Technical preparation
Behavioral questions
Frequently asked questions
- What therapeutic areas does Worldwide Clinical Trials focus on for their Clinical Research Associate roles?
- Worldwide Clinical Trials engages in diverse therapeutic areas for their Clinical Research Associate positions, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases. This offers a broad scope for professional development and experience.
- What is the typical work arrangement for a Clinical Research Associate at Worldwide Clinical Trials?
- While most of the site management efforts for the Clinical Research Associate role are performed remotely, there is a requirement for willingness to travel. This indicates a hybrid or flexible approach where remote work is primary, supplemented by necessary on-site visits.
- What specific systems proficiency is required for the Clinical Research Associate position?
- Proficiency in Microsoft Office, Clinical Trial Management Systems (CTMS), and Electronic Data Capture (EDC) Systems is required for the Clinical Research Associate role at Worldwide Clinical Trials. Demonstrating experience with these systems is crucial for success.
- Does Worldwide Clinical Trials require a specific type of degree for a Clinical Research Associate?
- Yes, Worldwide Clinical Trials requires a 4-year university degree or an RN/BSN in Nursing for their Clinical Research Associate positions. This educational background is a key qualification for applicants.
- What are the primary responsibilities of a Clinical Research Associate at Worldwide Clinical Trials?
- The primary responsibilities of a Clinical Research Associate involve managing research activities at clinical trial sites, predominantly for registries and non-interventional studies. This includes site identification, study start-up, data collection, training, site maintenance, and study close-out, with a focus on regulatory compliance and remote management.
- How does Worldwide Clinical Trials support its Clinical Research Associates?
- Worldwide Clinical Trials provides extensive support to its CRAs through assistance with regulatory submissions, TMF management, and by offering in-house CRAs for projects with significant site management needs. This ensures CRAs have the resources to succeed.
- What is the expected duration of experience for a Clinical Research Associate applicant at Worldwide Clinical Trials?
- Worldwide Clinical Trials typically requires at least 2 years of experience as a Clinical Research Associate. This ensures candidates have a solid foundation in clinical research practices and site management.
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