Clinical Research Associate II

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $92k - $122k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

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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

• Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs • Conduct site visits to determine protocol and regulatory compliance and prepare required documentation • Develop collaborative relationships with investigative sites and study vendors • Provide protocol and related study training to assigned clinical study sites • Attend disease indication, project-specific, regional investigator meeting and site booster training as required • Track enrollment, CRF data entry, protocol deviation trends and overall site issues • Serve as mentor/trainer for less experienced CRAs • Communicate site performance to the Clinical Study Team • Perform study-specific training with the project team • Perform SAE reconciliation and resolve discrepancies with study sites • Collaborate with the CST and clinical study sites to deliver study milestones, including startup, recruitment, database analyses and closeout • Support audit/inspection preparation and follow quality issues or findings through resolution • Provide site-level management for established protocols and portfolios • Co-monitor with CRAs and support site visits as needed • Assist with other assigned clinical responsibilities

🎯 Requirements

• BS/BA in a relevant scientific discipline • Minimum of 2+ years of relevant Clinical Operations experience • Minimum of 1+ years of monitoring experience • Experience in global oncology trials preferred • Efficient in Microsoft Word, Excel, PowerPoint and Outlook • Familiar with industry CTMS and data management systems • Thorough knowledge of ICH and associated regulatory guidelines • Excellent communication and interpersonal skills • Excellent organizational skills and ability to prioritize and multi-task • Fluent in English (writing and speaking) • Up to 70% travel

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Voluntary participation in the Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid Time Off • Wellness

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