Clinical Team Lead
加入我们重新定义为 CRO 工作意味着什么。当你在 Rho 工作时,它不仅仅是一个工作,你就成为了 Rho Factor 的一部分。我们是一个自豪的科学小伙子,他们喜欢一起应对大挑战。我们不是典型的 CRO,我们也不试图这样做。在这里,好奇心被鼓励,新方法欢迎,合作是我们所做的一切核心。无论你是数据巫师,分析天才,项目主智或其他角色,你都会直接融入 Rho Factors 方程。期待大量的疯狂笑话,偏离性人格,自发的头脑风暴和支持社区,人们真正关心他们的工作。你将有机会体验一个充满繁荣的公司,具有真正的稳定性 - 金融,劳动力和企业,该公司在长期且丰富的职业生涯中创造了一个安全的创新和发展环境。我们目前正在聘请一名临床团队领导者加入我们的团队!作为临床团隊领导人 II,你是推动临床研究项目成功的组成部分。你将有权独立管理并保持对分配项目的临床运营部分的所有权。你将向这些项目所分配的 CRA 提供指导和培训。此外,你将监督有关 CRA 和网站性能规划和监督的所有运营方面以及确保站点和 CRA 按照研究协议,ICH/GCP 指南和联邦法规运行。我们的临床运营团队会告诉你,加入 Rho 是他们从满意度,财务回报和职业增长方面最好的职业举措之一,这就是我们在集团中拥有如此的稳定性!这个角色可以在美国任何地方都远程。你将做什么:·积极推动项目成功,包括与跨功能学习领导层密切合作开发和实施运营策略 · 确定和减轻临床风险,并为制定质量风险管理计划做出贡献 · 提供专业审查研究协议和其他研究材料 (例如 CRF)· 开发和管理临床运营时间表,指标,资源,预算和活动 · 开发监测工具和计划 · 根据部门生产力预期的规划和现场绩效监督的操作方面负责 · 创建和进行培训会议,包括调查人员在内的会议。
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Join us in redefining what it means to work for a CRO.
When you work at Rho, it’s more than just a job—you become part of the Rho Factor. We’re a proud bunch of science nerds who love tackling big challenges together. We’re not your typical CRO, and we’re not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.
Whether you’re a data wizard, analytical genius, project mastermind, or any other role, you’ll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work—and each other.
You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career.
We are currently hiring a Clinical Team Lead to join our team! As Clinical Team Lead II, you are integral in driving clinical research project success. You will have the opportunity to independently manage and maintain ownership of the clinical operations portion of assigned projects. You’ll provide direction to and training CRAs assigned to those projects. In addition, you will oversee of all operational aspects related to the planning and oversight of CRA and site performance as well as ensuring that sites and CRAs operate in compliance with study protocols, ICH/GCP guidelines, and Federal Regulations.
Our Clinical Operations Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!
This role can be remote anywhere in the US.
What You'll Be Doing:
- Proactively drive project success, including working closely with cross-functional study leadership to develop and implement operational strategies
- Identify and mitigate clinical risks, as well as contribute to the development of the quality risk management plan
- Provide skilled review of study protocols and other study materials (e.g. CRF)
- Develop and manage clinical operations timelines, metrics, resourcing, budget and activities
- Develop monitoring tools and plans
- Accountable for operational aspects of planning and oversight of site performance in accordance with departmental productivity expectations
- Create and conduct training sessions including investigator meetings, conferences, and team trainings
- Determine and drive the study start up process (track and report progress, review data), ensuring that all sites are selected and supplies provided in accordance with study expectations
- Provide status updates to project management and sponsors
- Lead regular clinical team teleconferences
- Work effectively with Site staff, as needed, serving as an escalation point for CRAs as issues arise
- Manage clinical Site communication and documentation of decisions, including mass correspondence to sites regarding study updates
- Participate in the RFP process, including internal and external business development meetings
- Review monitoring visit reports and ensure finalization is within contractual timeline
- May assist Project Managers with project management tasks as assigned
- Support the management and development of In-house CRAs and CRAs
Requirements
- 8+ years of clinical research experience within the CRO, pharmaceutical, or biotechnology industry, including 1-2 years of experience leading the clinical operations function within clinical trials and at least 2 years of on-site monitoring experience; preferred therapeutic experience in Neurology and Pain.
- BA/BS, preferably in a life science, nursing, pharmacy or related field
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s.
- Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome.
- High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another.
- Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience. We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions.
- Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment. We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us.
- Ability to travel, as needed, possibly up to 25%
Benefits
A few more things to know about us:
Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave.
Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.
As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $130,000-$150,000 per year.
EOE. Veterans/Disabled
Originally posted on Himalayas