Clinical Research Associate

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September 26

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BeOne Medicines

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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 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.

10,000+ employees

Founded 2010

📋 Description

• Execute clinical monitoring activities at clinical trial sites in accordance with ICH-GCP, local regulations, and SOPs • Perform feasibility, site identification, selection and evaluation; support site lists and recruitment targets • Provide protocol and study training to assigned sites • Conduct monitoring visits (pre-study, initiation, routine, closeout) and co-monitoring visits as required • Complete monitoring visit reports per ICH-GCP and BeOne standards • Manage sites and site performance: track regulatory submissions, recruitment, CRF completion, data query resolution • Establish regular communication with sites and report progress, issues and proposed actions to Clinical Operations • Ensure inspection readiness of the study and sites; facilitate SOVs, site audits and inspections • Collaborate with Regional Clinical Operations Manager and study sites to meet study milestones (startup, recruitment, database analyses, closeout) • Evaluate quality and integrity of site practices; escalate quality/GCP issues and propose CAPAs • Support study start-up and provide local expertise; attend indication and CRA training as required

🎯 Requirements

• BS in a relevant scientific discipline • Minimum of 2 years of monitoring experience (CRA) • At least 2 years of CRA monitoring experience in the pharmaceutical or CRO industry • Experience in oncology/hematology trials preferred • Thorough knowledge of ICH and GCP and associated regulatory guidelines • SSU experience is considered a plus • Excellent communication and interpersonal skills • Fluent in English & French (writing and speaking) • Excellent organizational skills and ability to prioritize and multi-task • Computer Skills: Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook • Willingness to travel up to 60%