站点激活专员/合同谈判师
Site Activation Specialist/ Contract Negotiator
职位名称：站点激活专员/合同谈判员
工作地点：美国肯塔基州列克星敦
工作地点类型：远程
工作合同类型：全职
职位级别：
职位概述
在适度监督下，根据法规、标准操作规程（SOP）和项目要求，在区域或国家层面执行可行性、站点识别、监管、启动和维护活动。
准备和管理站点文件；审查和与站点和赞助方谈判站点文件和合同；维护、审查并报告站点绩效指标；作为研究站点的主要联系人；跟踪站点适当文件的完成情况；确保合同完全执行；并建立项目时间表。在适度的监督和指导下，根据适用的当地和/或国际法规、标准操作规程（SOP）、项目要求和合同/预算指南，在国家/地区层面执行与站点激活相关的任务。可能还包括维护活动。
核心职责
- 在适度的监督和指导下，根据适用的法规、SOP 和工作指令，对指定研究中的研究站点执行可行性、站点激活和部分维护活动，与站点激活经理（SAM）、项目管理团队及其他必要部门密切合作。在高级员工的指导下，审查文件的完整性、一致性和准确性。
- • 准备站点文件，并审查其完整性和准确性。
- • 通知团队成员各站点的监管、合同和其他文件的完成情况。
- • 将已完成的文件分发给站点和内部项目团队成员。
- • 使用准确且完整的项目特定信息更新和维护内部系统、数据库、跟踪工具、时间表和项目计划。
- • 审查、跟踪并跟进所需文件的进度、审批和执行情况，例如问卷、CDAs、监管/伦理批准、知情同意书（ICF）和研究者手册（IP）发布文件。需要在特定领域具备专业知识，通常通过 extensive 工作经验和/或教育获得。
任职资格
- 需要生命科学或相关领域的学士学位
- • 其他 1-3 年临床研究或其他相关经验；或同等经验
查看英文原文
Job Title: Site Activation Specialist/ Contract Negotiator
Job Location: Lexington, Kentucky, United States of America
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Job Overview
Under moderate supervision, executes the feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level.
Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines. With moderate oversight and supervision, perform tasks at a country/region level associated with site activation activities in accordance with applicable local and/or international
regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.
Essential Functions
- With moderate oversight and supervision, perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.
- • Prepare site documents, reviewing for completeness and accuracy.
- • Inform team members of completion of regulatory, contractual, and other documents for individual sites.
- • Distribute completed documents to sites and internal project team members.
- • Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
- • Review, track and follow up the progress, approval and execution of required documents such as questionnaires, CDAs, regulatory/ethics approvals, Informed Consent Form (ICF) and Investigator Pack (IP) release documents. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.
Qualifications
- Bachelor's Degree Life sciences or a related field required and
- • Other 1 - 3 years clinical research or other relevant experience; or equivalent combination of education, training and experience required
- • With 3 years of experience in a healthcare environment, or equivalent combination of education, training and experience.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $49,200.00 - $123,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
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Originally posted on Himalayas