Clinical research associate.

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General Description: The 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. Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region. The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.

Supports start-up and provides local expertise. Provides protocol and related study training to assigned sites. Conducts monitoring (pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs).

Conducts co-monitoring visits, if required. Completes monitoring visit reports in accordance with ICH-GCP, Be One Medicines standards and SOP. Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.

Establishes regular lines of communication with sites and reports site progress, issues and proposed actions to Clinical Operations. Ensures inspection readiness of the study and sites. Collaborates with the Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.).

Attends disease indication project specific training and general CRA training as required.

Facilitates Study Oversight

Visits (SOVs), site audits and/or inspections, as required. Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.



BS in a relevant scientific discipline and minimum of 2 years of monitoring experience.

Experience in oncology global trials preferred.

Other Qualifications: Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines At least 2 years of (CRA) monitoring experience in the pharmaceutical or CRO industry Experience in oncology/hematology trials preferred Excellent communication and interpersonal skills Excellent organizational skills and ability to prioritize and multi-task Fluent in English & Italian (writing and speaking) Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS Power Point and Outlook.

Fosters Teamwork

Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Equal Opportunity Statement: We are proud to be an equal opportunity employer. Be One 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.

About Be One: Be One 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 Be One, please visit and follow us on Linked In, X (formerly known as Twitter), Facebook and Instagram.

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Collaborative Spirit

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8ksvnq