Clinical Research Associate II

🔥 23 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

• Conduct and coordinate clinical monitoring activities in accordance with GCPs, SOPs, ICH-GCP guidelines, and local regulations • Conduct site visits including PSSV, SIV, IMV, and COV • Function as the site manager and maintain relationships and communication with site personnel • Monitor data quality and patient safety through monitoring and site education • Assess safety and efficacy of investigational products and/or medical devices • Determine protocol and regulatory compliance and prepare required documentation • Develop collaborative relationships with investigative sites and study vendors • Provide protocol, study, and project-team training • Track enrollment, CRF data entry, protocol deviations, and site issues • Mentor and train less experienced CRAs • Communicate site performance to the Clinical Study Team • Perform SAE reconciliation and resolve discrepancies with study sites • Collaborate with the CST and clinical study sites to deliver study milestones • Attend regional investigator meetings and site booster visits as required • Support audit and inspection preparation and follow quality issues to resolution • Provide site-level management for established protocols and portfolios • Co-monitor with CRAs and support site visits as needed

🎯 Requirements

• BS/BA in a relevant scientific discipline • Minimum 2+ years of relevant Clinical Operations experience • Minimum 1+ years of monitoring experience • Understanding of clinical trial processes and thorough knowledge of ICH and associated regulatory guidelines • Fluent English in writing and speaking • Spanish is a plus • Global oncology trial experience preferred • Excellent communication and interpersonal skills • Excellent organizational skills with ability to prioritize and multitask • Efficient in Microsoft Word, Excel, PowerPoint, and Outlook • Familiarity with industry CTMS and data management systems • Willingness and ability to travel up to 70%

🏖️ Benefits

• Equal opportunity employer • Up to 70% travel associated with the role