Clinical Research Associate I – Oncology

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $80k - $105k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 1%

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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

• Conduct pre-study, initiation, routine monitoring, closeout, and co-monitoring visits for Oncology and Hematology clinical trials • Ensure study milestones, including startup, recruitment, database analyses, and closeout, are met • Attend onboarding, disease indication, project-specific, and CRA training • Document monitoring activities according to ICH-GCP and BeOne standards • Conduct Quality Oversight Visits as requested • Complete monitoring visit and QOV reports on time • Assist with investigator/site identification and Ethics Committee submissions • Facilitate clinical trial site contract and budget negotiations • Manage site queries and communications • Assist in managing clinical trials as required • Establish regular communication with sites and Clinical Operations Managers • Provide protocol and study training to assigned sites • Evaluate site practice quality and integrity, escalating quality issues as appropriate • Track regulatory submissions, recruitment, CRF completion, and data query resolution • Collaborate with the CRA Group and CRM on recruitment and contingency plans • Deliver quality data within timelines and ensure adherence to monitoring procedures, GCP, ICH, local regulations, and SOPs

🎯 Requirements

• At least 2 years of Clinical Research Coordinator experience in Oncology • Thorough knowledge of clinical trial processes, 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) • Efficient in Microsoft Word, Excel, PowerPoint, OneNote, and Outlook • Familiarity with industry EMR, CTMS, Site File Management, and data management systems • Bachelor’s degree or above in life sciences, pharmacy, nursing, or medical • Up to 70% multi-regional travel • Early Phase experience preferred • Hematology and Solid Tumor experience preferred

🏖️ Benefits

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