Clinical Research Associate II

🔥 2 hours ago

🇺🇸 United States – Remote

💵 $92k - $122k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 1%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Serve as the primary Clinical Research Associate and site manager • Conduct pre-study, site initiation, interim monitoring, and closeout visits • Build and maintain relationships with key site personnel • Monitor data quality and patient safety through monitoring and site education • Complete clinical monitoring activities in accordance with ICH-GCP guidelines, local regulations, and SOPs • Assess the safety and efficacy of investigational products and/or medical devices • Conduct site visits to determine protocol and regulatory compliance and prepare documentation • Develop collaborative relationships with investigative sites and study vendors • Provide protocol and study training to clinical study sites • 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 study-specific training with the project team • Reconcile Serious Adverse Events and resolve discrepancies with study sites • Collaborate with the Clinical Study Team and sites to deliver study milestones • Attend investigator meetings and site booster visits • Support audit and inspection preparation and resolve quality findings • Provide site-level management and co-monitoring support as needed

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