Clinical Research Associate I

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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

• Complete the required CRA Training Program, including instructor-led training, independent exercises, and in-field observation visits • Conduct site visits, including PSSV, SIV, IMV, and COV, and function as the site manager • Build and maintain relationships with key site personnel and ensure effective communication • Monitor data quality and patient safety through monitoring and site education • Perform and coordinate clinical monitoring activities in accordance with GCPs, SOPs, local regulations, and monitoring plans • Conduct site visits to assess protocol and regulatory compliance and prepare required documentation • Provide protocol and study-related training to assigned clinical study sites • Track enrollment, CRF data entry, protocol deviations, and site issues • Communicate site performance to the Clinical Study Team • Mentor or train less experienced CRAs when required • Perform study-specific training with the project team • Reconcile Serious Adverse Events and resolve discrepancies with study sites and the CST • Collaborate with the CST and sites to deliver study milestones, including startup, recruitment, database analyses, and closeout • Attend investigator meetings and site booster visits as required • Support audit and inspection preparation and follow quality findings through resolution • Provide site-level management, co-monitoring, and support for assigned study sites

🎯 Requirements

• BS/BA in a relevant scientific discipline • 1+ years of experience in a clinical research associate position is preferred • 5+ years of relevant Clinical Operations experience or experience working in oncology global trials is preferred • Excellent communication and interpersonal skills • Excellent organizational skills with ability to prioritize and multitask • Fluent English in writing and speaking • Up to 70% travel availability • Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook • Familiarity with industry software such as CTMS, investigational product systems, and data management systems