Clinical Research Associate

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BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne continues to grow rapidly, offering challenging and exciting opportunities for experienced professionals. We seek scientific and business professionals who are highly motivated, collaborative, and share our passionate interest in fighting cancer.

General Description

• The CRA executes clinical monitoring activities at trial sites, ensuring compliance with ICH guidelines, GCP, local regulations, and SOPs.
• Performs monitoring related to site selection, initiation, conduct (recruitment, data quality), and timely trial completion within the region.
• Collaborates closely with the Regional Clinical Operations Manager to adhere to study timelines and quality standards.
• Identifies gaps, proposes CAPA, supports start-up, and provides local expertise.
• SSU experience is a plus.

CRA Activities

• Perform feasibility assessments, site identification, selection, and evaluation, supporting recruitment targets.
• Provide protocol and study training to sites.
• Conduct monitoring visits (pre-study, initiation, routine, closeout) per plan and SOPs.
• Manage site performance, track regulatory submissions, recruitment, CRF completion, and data queries.
• Maintain communication with sites, report progress, issues, and actions.
• Ensure inspection readiness of sites and study documentation.
• Assist in meeting study milestones and facilitate study oversight visits and audits.
• Evaluate site practices, escalate issues, and propose corrective actions.
• Identify site issues, gaps, and promote operational excellence and innovation.

Education & Experience

• BSc in a relevant scientific discipline with at least 2 years of monitoring experience.
• Experience in oncology trials preferred.

Qualifications

• Thorough understanding of clinical trial processes, ICH, and regulatory guidelines.
• At least 2 years of CRA monitoring experience in pharma or CRO industry.
• Experience in oncology / hematology trials is preferred.
• Excellent communication, organizational, and multitasking skills.
• Fluent in English and Spanish (speaking and writing).

Additional Skills

Proficiency in MS Word, Excel, MS Project, PowerPoint, Outlook. Travel up to 60%.

Core Competencies

• Teamwork, feedback, self-awareness, inclusivity, initiative, entrepreneurial mindset, continuous learning, adaptability, results orientation, analytical thinking, financial acumen, clear communication.

We are an equal opportunity employer valuing diversity. Employment decisions are based on qualifications, merit, and business needs.

• Seniority level : Entry level
• Employment type : Full-time
• Job function : Research, Analysis, IT

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