Senior Clinical Research Associate

Overview

BeOne Medicines is seeking a Senior Clinical Research Associate to join our team, with a focus on oncology / hematology trials. We look for scientific and business professionals who are highly motivated, collaborative, and share our passion for fighting cancer.

Responsibilities

• The Senior CRA executes clinical monitoring activities at clinical trial sites in accordance with ICH guidelines and GCP, local regulations, and BeOne SOPs.
• Performs monitoring activities related to site selection, initiation, conduct (recruitment, data quality) and timely completion of oncology / hematology trials within the assigned region.
• Collaborates closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.
• Identifies gaps and areas for improvement and proposes CAPA.
• Supports start-up and provides local expertise.
• SSU experience is considered a plus.
• Perform feasibility, site identification, selection and evaluation, supporting initial list of sites and recruitment targets.
• 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 standards and SOPs.
• Manages sites and site performance by tracking regulatory submissions, recruitment, 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 Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (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 inspections, as required.
• Evaluates the quality and integrity of site practices and escalates quality or GCP issues with Investigators and internal teams as appropriate.
• Anticipates and identifies site issues; proposes corrective and preventative actions; continually strives for operating excellence and innovation.

Education & Experience

Skills & Qualifications

Global Competencies

Equal Opportunity

We are proud to be an equal opportunity employer. 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 applicable law. All employment is decided on the basis of qualifications, merit, and business need.

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