Clinical Research Associate II

🔥 0 minutes 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

• Assume the role of a primary CRA and function as the site manager • Conduct site visits, including PSSV, SIV, IMV, and COV • Build and maintain relationships with key site personnel • Monitor data quality and patient safety through monitoring and site education • Complete all aspects of clinical monitoring in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs • 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 • Provide protocol and study training to assigned clinical study sites • Maintain oversight of site performance by tracking enrollment, CRF data entry, protocol deviation trends, and site issues • Mentor and train less experienced CRAs • Communicate site performance to the Clinical Study Team • Perform study-specific training with the project team • Reconcile Serious Adverse Events 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 findings to resolution • Provide site-level management and co-monitoring support

🎯 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 • 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 • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness

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