Senior Clinical Research Associate

🕒 May 19

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BeOne Medicines

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10,000+ employees

Founded 2010

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.

📋 Description

• Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices • Conduct site visits to determine protocol and regulatory compliance, and prepare required documentation • Develop collaborative relationships with investigative sites, and study vendors • Track enrollment status reports to ensure study sites stay on track to meet enrollment goals • Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues • Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks as needed • Perform Serious Adverse Event (SAE) reconciliation and work with study sites and CRAs to resolve discrepancies • Collaborates with CST and clinical study sites to ensure timely delivery of study milestones.

🎯 Requirements

• Minimum of 4-6 years of relevant Clinical Operations experience • Minimum of 3-4 years of (CRA) monitoring experience in the pharmaceutical or CRO Industry • Excellent communication and interpersonal skills • Excellent organizational skills and ability to prioritize and multi-task.

🏖️ Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness