Clinical Research Associate

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Clinical Research Associate

Apply locations United Kingdom Remote time type Full time posted on Posted 2 Days Ago job requisition id R27730

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 at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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.
• May be assigned to CRA activities or start-up activities, depending on experience and project needs.
• Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region.
• Identifies gaps and areas for improvement and proposes CAPA.
• Supports start-up and provides local expertise.
• 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.

CRA activities:

• Perform feasibility, site identification, selection and evaluation, preparing/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, BeiGene 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 action 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 (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.
• Anticipates and identifies site issues; proposes corrective and preventative actions; identifies gaps and utilizes opportunities. Constantly strives for operating excellence, questions status-quo and promotes innovation.

Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook.

Qualifications:

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines.
• Ideally 2+ years of (CRA) monitoring experience in the pharmaceutical or CRO industry.
• Excellent communication and interpersonal skills.
• Excellent organizational skills and ability to prioritize and multi-task.
• Fluent in English (writing and speaking).

Travel: up to 60%

Global Competencies:

• 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

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

About Us

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. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeOne, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.

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At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.