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临床研究专员(CRA II/高级)- 代谢 - 美国任何地区

Clinical Research Associate (CRA II/Senior) - Metabolic - US Any Region

其他限定地区(需当地身份)
公司Parexel
薪资未公开
工作地点United States
地域资格限定地区(需当地身份)
时区要求日间重叠约 9 小时,基本正常作息
用工类型Full Time
发布时间14 天前
数据来源Himalayas
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注意地域限制:该职位明确限定在 United States 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。

当我们的价值观一致时,我们能够实现无限可能。

在Parexel,我们都有相同的目标——改善全球健康。从临床试验到监管、咨询和市场准入,我们提供的每项临床开发解决方案都建立在一个特别的基础上——对我们所做工作的深刻信念。
无论我们在Parexel做什么,每个人都在为最终能惠及患者的疗法开发做出贡献。我们认真对待工作,以同理心去完成,并致力于带来改变。

关于Parexel

Parexel是领先的全球临床开发合作伙伴,为生命科学行业提供以洞察为导向的临床和咨询服务。全球拥有22,000多名员工,我们与生物制药公司和研究机构合作,设计并实施以患者为中心的临床试验,扩大患者参与度,使研究成为任何地方任何人的治疗选择。

我们以专注、敏捷和共同目标开展工作,迅速响应患者需求,加速新疗法的交付。我们鼓励大胆思考,快速适应变化,并不断推动临床研究的速度和质量达到新高度。我们正在扩大团队,寻找有才华的人才来推动行业领先创新,With Heart®。

关于该职位
我们正在寻找一位具有代谢/肝病(MASH)或肥胖监测经验的临床研究助理(CRA)加入我们的团队。作为CRA,您将负责从站点识别到结题的临床站点管理,作为站点团队的主要联系人,帮助确保研究质量、患者安全、法规合规性和准确的临床数据。

您将进行现场监查活动,建立并维护高效的站点关系,解决站点问题,并支持入组和研究执行。Parexel提供世界级的技术、根据您的经验量身定制的培训、跨治疗领域的合作机会以及在临床研究中的持续成长路径。

主要职责
· 在指定的临床站点进行资格评估访问(QV)、站点启动访问(SIV)、监查访问(MV)和终止访问(TV),并及时准备访问和联系报告。
· 管理从站点识别到结题的站点质量和交付。
· 作为指定临床站点的主要联系人,解答问题并解决问题,以支持研究的顺利执行。
· 监督

查看英文原文

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.
About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®.

About the Role
We are seeking a Clinical Research Associate (CRA) with Metabolic/MASH or Obesity monitoring experience to join our team. As a CRA, you will manage clinical sites from identification through closeout, serving as the primary point of contact for site teams and helping ensure study quality, patient safety, regulatory compliance, and accurate clinical data.

You will conduct onsite monitoring activities, build and maintain productive site relationships, address site issues, and support enrollment and study delivery. Parexel provides world-class technology, training tailored to your experience, opportunities to work across therapeutic areas, and pathways for continued growth within clinical research.

Key Responsibilities
· Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at assigned clinical sites, and prepare timely visit and contact reports.
· Manage site quality and delivery from site identification through closeout.
· Serve as the primary point of contact for assigned clinical sites, addressing questions and resolving issues to support successful study execution.
· Oversee study integrity and build effective relationships with investigators and site staff.
· Review trial performance at designated sites and help safeguard the rights, safety, and well-being of study participants in accordance with the protocol.
· Develop patient recruitment strategies with clinical sites to support enrollment timelines.
· Ensure compliance with approved standard operating procedures, study protocols and amendments, Good Clinical Practice, and applicable regulatory requirements.
· Evaluate the quality and integrity of reported data, site performance, and investigational product accountability.
· Monitor the completeness and quality of regulatory documentation and perform site document verification.

Candidate Profile
You'll thrive in this role if you bring:
· Strong site relationship management, problem-solving, and communication skills.
· The ability to work independently with urgency and limited oversight.
· A client-focused, flexible approach to assignments and continuous learning.
· The ability to manage multiple priorities, evaluate changing scenarios, apply study protocols, and meet project timelines.
· An ethical, patient-focused approach and strong attention to quality and detail.
· Comfort collaborating within a matrixed team and communicating clearly with internal and external stakeholders.

Required Qualifications

  • At least 18 months of direct onsite monitoring experience as a Clinical Research Associate.
  • Metabolic/MASH and/or Obesity clinical trial monitoring experience.
  • Bachelor's degree or equivalent in biological science, pharmacy, or another health-related discipline.
  • Knowledge of Good Clinical Practice, applicable regulatory requirements, and clinical trial processes.
  • Experience using a Clinical Trial Management System, an Electronic Document Management System, and Microsoft Office applications, including Excel and Word.
  • Strong interpersonal, written, verbal, organizational, and problem-solving skills.

Benefits and Compensation
· Health, Vision & Dental Insurance
· Tuition Reimbursement
· Vacation/Holiday/Sick Time
· Flexible Spending & Health Savings Accounts
· Work/Life Balance
· 401(k) with Company match
· Pet Insurance

For a complete list of benefits, please visit .

Some roles may be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.
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

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