临床研究预算分析师 - 临床试验
Clinical Research Budgeting Analyst - Clinical Trials
这是一个远程职位
临床研究预算分析师将负责及时准确地准备和维护资助临床试验的预算,包括与研究赞助商提供的预算进行对比审查,并在临床试验管理系统中设置研究付款里程碑。主要职责包括但不限于审查新研究路由表单和关键研究启动文件,将临床方案解析为预算里程碑的详细成本分析,为提交给IRB的知情同意书提供准确的患者成本描述,并根据合同/方案修订需要更新预算、里程碑和ICF信息。与合同分析师、监管团队、项目经理和内部财务部门紧密合作。将管理多个研究项目的大量工作流程,每个项目运作方式不同。
负责从临床研究方案中开发研究预算,并使用各种软件工具。在新临床研究设立过程中完成内部成本的全面评估和整合;在研究方案修订或重新评估研究成本后,将修订研究预算。利用并监督临床试验中作为PH&S服务部分的研究费率定价。
- 与合同分析师沟通,将研究预算信息整合到临床试验协议中;可能发起或参与合同谈判过程。
- 根据需要独立发起或更新每项研究的覆盖范围确定,并将特定研究的计费结构传达给临床团队和服务提供商。
- 参与研究受试者相关计费的管理,并在必要时为计费记录的审计提供支持。
- 收集并维护完整的费用和付款记录和统计数据;定期监控临床费用是否符合预先确定的预算/计费计划和/或预算和协议。
- 在研究部门内、整个医院以及参与临床研究的其他机构之间建立并促进积极的工作关系。
- 使用微软应用(Excel)和/或临床试验管理系统(Velos)设置研究付款里程碑和计费说明网格。
- 为个别医生研究人员提供支持并开发内部流程
查看英文原文
This is a remote role
The Clinical Research Budgeting Analyst will be responsible for the timely and accurate preparation and maintenance of budgets for sponsored clinical trials, including the comparative review against budgets offered by study sponsors and the set-up of study payments milestones in the Clinical Trial Management System. Main responsibilities include, but are not limited to, the review of New Study routing forms and essential study start-up documents, the itemized cost analysis and interpretation of clinical protocols into budget milestones, provide accurate patient cost descriptions for the ICF to be submitted to the IRB, and update budget, milestones, and ICF information as necessary per contract/protocol amendments. Work closely with contract analysts, regulatory team, program managers and internal finance groups. Will manage large volume workflow across multiple research programs, each of which function differently.
Responsible for the development of study budgets from clinical studies protocols and using various software tools. Will complete full evaluation and integration of internal cost during the set-up of a new clinical study; will revise study budgets following revision of study protocols or re-assessment of study cost. Utilize and oversee research rate pricing for PH&S services rendered as part of a clinical trial.
- Communicate with Contracts Analysts to integrate study budget information into clinical trial agreements; may initiate or participate in contract negotiation process.
- Independently initiate or update the coverage determination for each study as applicable and communicate specific study billing structure to the clinical teams and service providers.
- Participate in the administration of study-subject related billing as needed and provide support with the auditing of billing records.
- Collects and maintains complete records and statistics on expenses and payments; regularly monitors compliance of clinical expense to pre-determined budget/billing plan and/or budgets and agreements.
- Establishes and promotes positive working relationships within the research departments, throughout the hospital and between other institutions involved in clinical research.
- Responsible for the set-up of study payments milestones and Billing Instructions grids using Microsoft Applications (Excel) and/or the Clinical Trial Management System (Velos).
- Provides support to individual physician investigators and develop internal cost analysis for investigator initiated trials.
Providence Swedish caregivers are not simply valued – they’re invaluable. Join our team at Swedish Research and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to inspire and retain the best people, we must empower them.
Required qualifications:
- Bachelor's Degree --or-- · 4 additional years of related experience
- 6 years of direct experience in budget development, preferably in clinical trial or medical setting
Preferred qualifications:
- Master's Degree in Business or Healthcare Administration
- 4 years of research grants administration
Why Join Providence Swedish?
Our best-in-class benefits are uniquely designed to support you and your family in staying well, growing professionally and achieving financial security. We take care of you, so you can focus on delivering our mission of improving the health and wellbeing of each patient we serve.
Originally posted on Himalayas