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Senior Clinical Research Associate

đź•’ May 19

🇺🇸 United States – Remote

đź’µ $105.8k - $140.8k / year

⏰ Full Time

đźź  Senior

đź§Ş Clinical Research

đź‘» Ghost score 39%

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Logo of BeOne Medicines

BeOne Medicines

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

đź’Š 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.

đź“‹ Description

• Manage and oversee assigned clinical study sites to ensure data quality and patient safety • Perform and coordinate clinical monitoring activities according to GCPs and SOPs • Conduct site visits and prepare required documentation • Develop relationships with investigative sites and study vendors • Track enrollment and study-specific status reports • Mentor and train less experienced CRAs • Support the Clinical Study Manager with monitoring visit report reviews and managerial tasks • Perform study-specific project team training • Develop monitoring tools and forms • Reconcile Serious Adverse Events and resolve discrepancies • Review outstanding data reports and ensure data collection meets contractual guidelines • Manage site trends through dashboard review and ongoing risk assessment • Collaborate with clinical study teams and sites to deliver study milestones • Support audit and inspection preparation, responses, and resolution of findings • Provide site-level management and support to CRAs

🎯 Requirements

• BS/BA in a relevant scientific discipline • 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 • 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 • Willingness to travel up to 40-60% of the time

🏖️ Benefits

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

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