Clinical Research Associate

🔥 5 minutes ago

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Execute clinical monitoring activities at clinical trial sites in accordance with ICH guidelines, GCP, local regulations, and SOPs • Perform feasibility, site identification, selection, and evaluation • Prepare and support site lists and recruitment targets • Provide protocol and study training to assigned sites • Conduct pre-study, initiation, routine monitoring, and closeout visits • Conduct co-monitoring visits when required • Complete monitoring visit reports according to ICH-GCP, BeOne standards, and SOPs • Manage site performance by tracking regulatory submissions, recruitment, CRF completion, and data query resolution • Establish communication with sites and report progress, issues, and proposed actions to Clinical Operations • Ensure inspection readiness of studies and sites • Collaborate with the Regional Clinical Operations Manager and sites to deliver study milestones • Facilitate Study Oversight Visits, site audits, and inspections as required • Evaluate site practice quality and integrity, escalating quality or GCP issues • Identify site issues, propose corrective and preventative actions, and identify improvement opportunities • Promote operating excellence, innovation, and continuous improvement

🎯 Requirements

• Ideally 2–5 years of CRA monitoring experience in the pharmaceutical or CRO industry • Excellent communication and interpersonal skills • Excellent organizational skills and ability to prioritize and multitask • Fluent in English, writing and speaking • Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook • Thorough knowledge of clinical trial processes, ICH guidelines, and associated regulatory guidelines

🏖️ Benefits

• Equal opportunity employment • Travel up to 60%