Clinical Research Associate I (CRA I) - Oncology

Responsibilities

• Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if require
• Conducts co-monitoring visits, if required
• Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
• Attends onboarding, disease indication and project specific training and general CRA training as required
• Documents monitoring activities appropriately following ICH-GCP and BeOne standards
• Conducts Quality Oversight Visits (QOV), as requested
• Completes monitoring visit/ QOV reports timely
• Assists with investigator/site identification
• Assists site to prepare Ethics Committee submissions
• Facilitates clinical trial site contract and budget negotiation
• Manages site queries and communications
• Assists in managing clinical trials, if required
• Establishes regular lines of communication with sites and COMs
• Provides protocol and related study training to assigned sites
• Evaluates the quality and integrity of site practices – escalating quality issues as appropriate
• Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
• Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed
• Performs additional task as assigned

Preferred

• Early Phase
• Hematology and Solid Tumor Experience

Benefits

• Non-Commercial roles are eligible to participate in the annual bonus plan.
• All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards.
• Voluntary participation in the Employee Stock Purchase Plan.
• Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide.
• Cambridge, Massachusetts, USA
• https://beonemedicines.com
• Distribution of Different Job Fields Receiving Sponsorship
• Represents job field similar to this job
• Engineering and Development
• Management and Executive
• Accounting and Finance
• Sales
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• Legal and Compliance
• Marketing
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• Trends of Total Sponsorships
• *2026
• (22)
• 2025
• (20)
• Late Stage
• Leadership Team
• Joao Barreiro
• Chief Privacy & Data Ethics Officer
• Recent News
• FiercePharma
• With FDA approval, Lilly’s BTK drug Jaypirca enters first-line CLL

Qualifications

• Efficient in Microsoft Word, Excel, PowerPoint, OneNote, and Outlook
• Familiar with industry EMR, CTMS, Site File Management, and data management systems
• At least 2 years of Clinical Research Coordinator experience in Oncology
• Understands clinical trial processes with a 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)
• Bachelor's degree or above in life sciences, pharmacy, nursing or medical
• Early Phase
• Hematology and Solid Tumor Experience

Required skills

• Clinical Trial Processes, Early-Phase Clinical Trials, Hematology, ICH-GCP and Regulatory Guidelines, Oncology Clinical Research, Solid Tumor Experience

Preferred skills

• Early Phase, Hematology and Solid Tumor Experience

Experience

• 2+ years