Research Associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8k85ap

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, BeOne 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. 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 Fluent in English & Italian (writing and speaking) Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook.

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.

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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8k85ap