高级临床研究助理-美国西部海岸-FSP
Senior Clinical Research Associate - US - West Coast - FSP
当我们的价值观一致时，我们能达到什么样的目标都没有限制。在 Parexel,我们都有相同的目标 - - 改善世界健康。从临床试验到监管，咨询和市场准入，我们提供的每一个临床开发解决方案都是基于某种特殊的东西 - - 我们对所做的事情深厚的信念。无论我们在 Parexal 做什么，我们每个人都有助于发展一种治疗最终会有益于患者。我们把工作当作个人的，我们以同情感而做，我们致力于改变。临床研究合伙人 (CRA) 将成为客户的监测团队成员，并为个别临床试验和/或计划提供监控专业知识。关键责任活动监督 · 进行内部和外包临床现场监测活动，以确保遵守良好的临床实践 (GCP),标准操作程序 (SOP) 和学习协议 · 在启动/可行性期间与研究小组合作，开展站点识别和评估任务。·确定根本原因，积极升级和解决 CRA 和站点性能问题通过与利益相关者合作。· 根据需要，向较少经验的团队成员提供监测专业知识，辅导和培训 · 建立积极的工作关系并主动寻求现场团队 （例如主要调查人员，研究协调员，药剂师，现场管理）的反 · 与研究团队和网站合作开展现场宣传活动，包括招聘和保留患者战略 · 在过程中提供输入和领导跨职能团队以确定研究的监控策略 （基于风险的监控）如需 · 使用区域知识来本地化研究流程和文件 · 代表监督在调查人员会议上如有必要 · 根据要求执行其他任务协作关系 · 与研究团队和利益相关者有效合作，进行网站评估，确定性能问题，并实施与项目目标和运营效率一致的解决方案。技能：· 在国内旅行的能力 · 自主工作能力以及团队环境中的能力 · MS Office 365 （例如 Word,Excel,PowerPoint,Outlook,SharePoint）的熟练知识 ·优秀的口头和书面沟通技巧和强大的组织能力 知识和经验：· R
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When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
The Clinical Research Associate (CRA) will be a member of the client’s Monitoring team and provide monitoring expertise to individual clinical trials and/or programs.
Key Accountabilities
Oversight of activities
· Conduct and provide support for in-house and outsourced clinical site monitoring activities to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs) and study protocols
· Collaborate with study teams during start-up/feasibility and conduct site identification and assessment tasks.
· Identify root causes and proactively escalate and resolve CRA and site performance issues through collaboration with stakeholders
· Provide Monitoring expertise, mentoring and training to less experienced team members as required
· Build positive working relationships and proactively seek feedback from site teams (e.g., Principal Investigators, Study Coordinators, Pharmacists, Site Administration)
· Partner with study teams and sites in conducting site outreach activities, including patient recruitment and retention strategies
· Provide input and lead cross-functional teams through the process to determine monitoring strategy (risk-based monitoring) for studies as required
· Use regional knowledge to localize study processes and documents where possible
· Represent Monitoring at Investigator Meetings as required
· Perform other tasks as required
Collaborative relationships
· Collaborates effectively with study teams and stakeholders to conduct site assessments, identify performance issues, and implement solutions that align with project goals and operational efficiency.
Skills:
· Ability to travel domestically
· Demonstrates ability to work independently and in a team environment
· Proficiency with MS Office 365 (e.g., Word, Excel, PowerPoint, Outlook, SharePoint)
· Excellent oral and written communication skills and strong organizational abilities
Knowledge and Experience:
· Relevant clinical research experience (i.e., biotechnology, pharmaceutical, Contract Research Organization (CRO), medical device)
· Demonstrates working knowledge of GCP, ICH guidelines and FDA regulations
· Experience in Oncology preferred
· 5+ years of relevant monitoring experience
Education:
· BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Originally posted on Himalayas