[Remote] Clinical Research Associate I (CRA I) - Oncology

Note: The job is a remote job and is open to candidates in USA. BeOne is hiring a Clinical Research Associate I to monitor Oncology and Hematology clinical trials within the country. The role ensures timely, high-quality trial data and adherence to GCP, ICH, local regulations, and company SOPs while supporting study sites and milestones.

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

Skills

• 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

Benefits

• Remote (US)
• 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
• All employees are eligible to voluntarily participate in the Employee Stock Purchase Plan
• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

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