R35436 CRA II/SCRA, 北京

• 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 BeiGene 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

Additional Job Description

• Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines

• 1-3 years or more (SCRA) monitoring experience in the pharmaceutical or CRO industry

• Excellent communication and interpersonal skills

• Excellent organizational skills and ability to prioritize and multi-task

• Fluent in English (writing and speaking)

百济神州全球胜任力

当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。

●团队协作

●提供并征求坦诚及可行的反馈

●自我认知

●兼容并蓄

●积极主动

●开拓精神

●持续学习

●拥抱变化

●结果导向

●分析性思维/数据分析

●卓越财务

●清晰沟通

BeOne Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

●Fosters Teamwork

●Provides and Solicits Honest and Actionable Feedback

●Self-Awareness

●Acts Inclusively

●Demonstrates Initiative

●Entrepreneurial Mindset

●Continuous Learning

●Embraces Change

●Results-Oriented

●Analytical Thinking/Data Analysis

●Financial Excellence

●Communicates with Clarity

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