CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs. CRA performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/onco-hematology clinical trials within the assigned country/region. May be assigned to CRA activities or start-up activities, depending on experience and project needs.

CRA is responsible for collaborating closely with the Country and Regional Clinical Study Teams to ensure study timelines are adhered to and required quality standards are maintained. CRA supports start-up and provides local expertise. Complete appropriate therapeutic, protocol and clinical research training/CRA training to perform job duties.

Gain experience in BeOne and study procedures by working with experienced clinical staff. Provide protocol and related study training to assigned sites. Conduct onsite/remote pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs.

Conduct co-monitoring visits, if required. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation, in accordance with ICH-GCP, BeOne standards and SOPs. Manage sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with Good Clinical Practice (GCP) / International Conference on Harmonization (ICH)



and local regulatory requirements.

Ensure inspection readiness of the study and sites Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations. Collaborate with Country and Regional Clinical Study Managers and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.) Facilitate Study Compliance Visits (SCVs), site audits and/or inspections, as required Evaluate the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate. May review visits reports, following-up on issue resolution and communicating with the Country/Regional Clinical Study Manager on significant risk identified and action proposed.

May serve as subject matter expert for clinical operations, country regulations and monitoring-related activities. May serve as subject matter expert for clinical operations and CRA-related activities; BS in a scientific or healthcare discipline preferred and at least 3 - 5 years of monitoring experience.

Experience in oncology/onco-hematology global trials preferred Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and associated regulatory guidelines. At least 3 - 5 years of (CRA)



monitoring experience in the pharmaceutical or CRO industry. An equivalent combination of education, training, and experience may be considered.

Experience in oncology/onco-hematology trials preferred Excellent communication and interpersonal skills Ability to establish and maintain effective working relationships with coworkers, managers, and other internal/external stakeholders as applicable Excellent organizational and problem-solving skills and ability to prioritize and multitask Effective time management skills Written and verbal communication skills, including a good command of the English language and Italian Computer Skills: Efficient in Microsoft Word, Excel, PowerPoint, Outlook, and use of a laptop computer and iPhone. When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Analytical

Thinking/Data Analysis BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations.

We are committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.

Patients First Driving Excellence Bold Ingenuity

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📌 Research Associate (Milano)
🏢 Biotecnologie - Farmacia - Chimica
📍 Milano